Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2017 - (Recall #: Z-1235-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 27, 2015

Date Posted: March 1, 2017

Recall Number: Z-1235-2017

Event ID: 76386

Reason for Recall:

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.

Status: Terminated

Product Quantity: 579 units have entered into the distribution chain

Code Information:

TAOS, TC03

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated