—#153034

Product

The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.

FDA product code: KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K112229
Affected lot / code info: TAOS, TC03

Why it was recalled

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, there were no reports of patient injury as a result of the centrifugal pump leaks. Terumo Cardiovascular System's investigation into the incident has identified the cause of the leaks to be cracks in both the Top Housing and Magnet Back Housing of the pump. When the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.

Root cause (FDA determination)

Process control

Action the firm took

Customer Notification Letter/Response Form is being sent to all affected consignees.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 125 Blue Ball Rd, Elkton, Maryland 21921-5315

Distribution

Distribution pattern: Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall

Timeline

Recall initiated: 2015-05-27
Posted by FDA: 2017-02-22
Terminated: 2017-02-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153034. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.