Recall Register

Terumo Cardiovascular Systems Corp: FDA recalls

FDA enforcement reports name Terumo Cardiovascular Systems Corp as the recalling firm in 8 events. The events have 19 product records. The recalls started from 2011 to 2022. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

8 events, newest first.

FDA enforcement events of Terumo Cardiovascular Systems Corp
InitiatedProduct (first record)TypeClassRecordsStatus
3 Feb 2022Cardiovascular Procedure Kit catalog # 76645 & 73806DeviceClass II1Terminated
18 Dec 2017Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filter for Exhacorporeal Service is indicated for use only in the exhacorporeal circuit for…DeviceClass II1Terminated
12 May 2017Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.DeviceClass II1Terminated
25 Jul 2016Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time…DeviceClass II1Terminated
24 Aug 2015Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a…DeviceClass II7Terminated
6 May 2015Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.DeviceClass II1Terminated
28 Mar 2014Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431DeviceClass II1Terminated
1 Mar 2011Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1…DeviceClass II6Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Terumo Cardiovascular Systems Corp: events for each product type
TypeEvents
Device8
Terumo Cardiovascular Systems Corp: events in each class
ClassEvents
Class II8
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Terumo Cardiovascular Systems Corp, by the year that the recall started. The largest year is 2015, with 2 events.

Official channels

Cite this page

Recall Register. Terumo Cardiovascular Systems Corp: FDA recalls. https://recallregister.com/firm/terumo-cardiovascular-systems-corp/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Terumo Cardiovascular Systems Corp have?
Class II: 8 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Terumo Cardiovascular Systems Corp?
FDA event 89792, which the firm started on 3 Feb 2022. The first product in the record is: Cardiovascular Procedure Kit catalog # 76645 & 73806
How many FDA recalls of Terumo Cardiovascular Systems Corp have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.