RegWardenFDA facility compliance records
Facility

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

67 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2009: 2 recalls; 2010: 1 recalls; 2011: 1 recalls; 2012: 23 recalls; 2013: 8 recalls; 2014: 5 recalls; 2015: 5 recalls; 2016: 3 recalls, 2 inspections; 2017: 3 recalls, 1 inspections; 2018: 6 recalls; 2019: 1 recalls, 1 inspections; 2020: 3 recalls; 2021: 2 recalls, 1 inspections; 2022: 1 recalls; 2024: 1 recalls; 2025: 2 recalls2’091’101’1123’128’135’145’155’164’176’182’193’203’211’22’231’242’25’26
  • Recalls (67)
  • Inspections (5)

Devices registered here (1)

  • Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
    Product code DRY (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4330

Recalls & enforcement

20252 records
  • Class IIOngoing2025-05-28
    Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in vivo recalibration, affected probes may experience inaccuracy…
  • Class IIOngoing2025-03-03
    During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.
20241 record
  • Class IIOngoing2024-02-20
    Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage potentially requiring surgical or medical/pharmacological intervention
20221 record
20212 records
  • Class IITerminated2021-06-08
    intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local con…
  • Class IITerminated2021-04-16
    Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue …
20203 records
  • Class IITerminated2020-11-11
    Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)
  • Class IITerminated2020-08-25
    Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.
  • Class IITerminated2020-01-10
    These roller pumps were assembled with pump shafts that may fail at the location of the thread where a locknut is installed. The failure is associated with a noise that is atypical of roller pump operation. The noise is caused when an unsecured shaft end contacts the rotating pu…
20191 record
20186 records
  • Class IITerminated2018-10-17
    An intermittent failure which causes a blender initialization fault upon start-up or during an EPGS calibration attempt leads to the Central Control Monitor control sliders being disabled, such that the gas system can only be controlled by the local control knobs.
  • Class IITerminated2018-09-13
    The service manual was not updated at the time of the release of software version 1.30.
  • Class IITerminated2018-08-28
    Screws on a Terumo® Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resultin…
  • Class IITerminated2018-06-26
    H/Sat Hybrid Intensity Shift has been seen in a subset of the H/Sat population, which has resulted in an increase of Hybrids failing the H/Sat Color Chip Test which is an automated self-test when the device is powered on. This will not result in device inaccuracy, only Color Chip…
  • Class IITerminated2018-03-16
    Update to cooler-heater cleaning instructions.
  • Class IITerminated2018-01-19
    Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).
20173 records
  • Class IITerminated2017-12-18
    Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
  • Class IITerminated2017-05-12
    Kit was labeled with the incorrect Expiration Date of April 30, 2019.
  • Class IITerminated2017-02-20
    Terumo CVS initiated a voluntary recall for the Level Sensor II Pads and Level Sensor Gel Pads due to non-compliant labeling because the product expiration date is displayed in a format that may not be recognizable to all users.
20163 records
  • Class IITerminated2016-07-25
    Terumo Custom Cardiovascular Procedure Kits are labeled as Xcoating surface coated tubing, but tubing is non-coated
  • Class IITerminated2016-06-08
    Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
  • Class IITerminated2016-03-14
    Specific CDI® Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM Sensor Head Assemblys Thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. This may c…
20155 records
  • Class IITerminated2015-08-24
    Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators
  • Class IITerminated2015-08-07
    Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
  • Class IITerminated2015-05-06
    The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of the extracoporeal bypass circuit. It is intended for use only on the venous side. There is a remote possibility of minimal blood loss, fluid weeping, or dripping on the user.
  • Class IITerminated2015-05-01
    Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: - Implementing design changes and upgrades to improve …
  • Class IITerminated2015-02-06
    Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular inter…
20145 records
  • Class IITerminated2014-06-17
    An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
  • Class IITerminated2014-05-23
    During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
  • Class IITerminated2014-05-09
    There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood…
  • Class IITerminated2014-03-28
    Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo® Cardiovascular Procedure Kits
  • Class IITerminated2014-03-03
    During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.
20138 records
  • Class IITerminated2013-10-23
    During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow® Aortic Cannulae and Sarns" Venous Return Cannulae.
  • Class IITerminated2013-10-23
    Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufacturer confirmed a batch of product code 631508 was incorrectly labeled.
  • Class IITerminated2013-07-26
    Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Servi…
  • Class IITerminated2013-07-26
    TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results …
  • Class IITerminated2013-07-26
    The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Specifically, if the user is adjusting the System 1 centrifugal pump speed via the Central Control Monitor at the same time an alarm condition …
  • Class IITerminated2013-05-30
    Internal testing found certain Sarns" TCM II systems were released with incorrectly assembled heatsink assemblies which could cause the units to fail.
  • Class IITerminated2013-02-27
    Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted t…
  • Class IITerminated2013-01-07
    Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to rem…
201223 records
  • Class IITerminated2012-11-21
    The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed d…
  • Class IITerminated2012-11-14
    Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The resul…
  • Class IITerminated2012-10-16
    Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A se…
  • Class IITerminated2012-09-25
    Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, i…
  • Class IITerminated2012-09-25
    Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the major…
  • Class IITerminated2012-09-25
    Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failu…
  • Class IITerminated2012-09-24
    Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
  • Class IITerminated2012-09-20
    Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terum…
  • Class IITerminated2012-09-10
    Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo® Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a popula…
  • Class IITerminated2012-07-26
    Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The invest…
  • Class IITerminated2012-07-26
    Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the …
  • Class IITerminated2012-06-25
    Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust oc…
  • Class IITerminated2012-06-25
    Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions:…
  • Class IITerminated2012-06-22
    Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use, such as would occur with a backu…
  • Class IITerminated2012-06-22
    Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; …
  • Class IITerminated2012-06-22
    Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for the Terumo Advanced Perfusion System 1. Both were reported instances of users experiencing difficulty adjusting the System 1 Gas System local flow control knob.
  • Class IITerminated2012-06-22
    Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messa…
  • Class IITerminated2012-06-21
    Terumo® Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than on…
  • Class IITerminated2012-06-21
    Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single…
  • Class IIITerminated2012-06-20
    During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sarns" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an incorrect incorrect amperage rating identified on the name plate label. The mislabeling was i…
  • Class IITerminated2012-06-18
    Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to ha…
  • Class IITerminated2012-05-09
    During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged fr…
  • Class IITerminated2012-05-09
    During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from th…
20111 record
  • Class IITerminated2011-03-01
    Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
20101 record
  • Class IITerminated2010-11-01
    Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope (gain) and offset (bias) for Hematocrit/Saturation calculations. The accuracy on any cuvette size did not meet the specifications.
20092 records
  • Class IITerminated2009-10-02
    Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one inch connector supports instead of one 3/8 inch and two inch connector supports (See location of support…
  • Class IITerminated2009-08-12
    Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associa…

FDA inspections (5)

  • NAI2021-07-14
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2019-10-11
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2017-10-03
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2016-12-07
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2016-05-13
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “TERUMO CARDIOVASCULAR SYSTEMS CORPORATION (FEI 1828100) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1828100-terumo-cardiovascular-systems-corporatio/

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