Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2014 - (Recall #: Z-2028-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.

Product Classification:

Class II

Date Initiated: April 14, 2014

Date Posted: July 23, 2014

Recall Number: Z-2028-2014

Event ID: 68024

Reason for Recall:

During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.

Status: Terminated

Product Quantity: N/A

Code Information:

Lot No. RA07, Lot No. QP02

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated