TERUMO CARDIOVASCULAR SYSTEMS CORP.
14 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (14)
Registered facilities (1)
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION FEI 3000204839 · MD
Recalls & enforcement
20231 record
- Class IIOngoing2023-03-01Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.
20211 record
- Class IITerminated2021-03-02There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.
20191 record
- Class IITerminated2019-06-14Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component
20182 records
- Class IITerminated2018-12-20Presence of natural rubber latex is not declared in the label
- Class IITerminated2018-08-31The system's IFU contains a list of generators that the have been deemed compatible. Recent reports indicate that one energy platform is not compatible with the system. Therefore, it has been removed from the list of compatible generators within the IFU.
20171 record
- Class IITerminated2017-06-27Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.
20153 records
- Class IIITerminated2015-12-11Terumo Cardiovascular Systems (Terumo CVS) has received complaints of the CDI System 500 monitor displaying the H/S DISCONNECT AT CUVETTE error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for…
- Class IITerminated2015-05-27Terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected during priming of the bypass circuit and during CPB procedures. In each of the reported incidents,…
- Class IITerminated2015-01-05Terumo Cardiovascular Systems (Terumo CVS) is voluntarily recalling certain lots of Titan" Stabilizers and Titan" 360 Stabilizers because the Suction Tubing Clip may break when it is being attached to a Terumo CVS Hercules Stabilizing Arm. Although the clip is for convenience …
20142 records
- Class IITerminated2014-08-20Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the…
- Class IITerminated2014-04-14During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
20133 records
- Class IITerminated2013-12-12Sterility of medical devices intended for use in surgical procedures may be compromised.
- Class IITerminated2013-07-26Medical device used in cardiovascular procedures is defective.
- Class IITerminated2013-06-04Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “TERUMO CARDIOVASCULAR SYSTEMS CORP. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1828100-terumo-cardiovascular-systems-corp/
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