Facility

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

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

Key facts

14recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3000204839
Establishment type	Manufacture Medical Device
Location	125 BLUE BALL RD ELKTON, MD, US 21921
Registration status	Active · expires 2026
Parent company	TERUMO CARDIOVASCULAR SYSTEMS CORP. (owner-operator 1828100)
Brand names	PUMP TUBING WITH X-COATING

Activity by year

Recalls (14)
Inspections (3)

Devices registered here (1)

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Product code DWF (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4210

Recalls & enforcement

20231 record

Class IIOngoing2023-03-01
Some 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 IITerminated2021-03-02
There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture.

20191 record

Class IITerminated2019-06-14
Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

20182 records

Class IITerminated2018-12-20
Presence of natural rubber latex is not declared in the label
Class IITerminated2018-08-31
The 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 IITerminated2017-06-27
Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve.

20153 records

Class IIITerminated2015-12-11
Terumo 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 IITerminated2015-05-27
Terumo 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 IITerminated2015-01-05
Terumo 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 IITerminated2014-08-20
Terumo 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 IITerminated2014-04-14
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.

20133 records

Class IITerminated2013-12-12
Sterility of medical devices intended for use in surgical procedures may be compromised.
Class IITerminated2013-07-26
Medical device used in cardiovascular procedures is defective.
Class IITerminated2013-06-04
Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.

FDA inspections (3)

NAI2024-02-16
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2022-12-16
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-09-15
Voluntary Action Indicated · Compliance: 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.

All facilities operated by TERUMO CARDIOVASCULAR SYSTEMS CORP.

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 3000204839) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000204839-terumo-cardiovascular-systems-corporatio/

Not open yet

Alerts for TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.