Z-1235-2017Class II

The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single...

Name: Z-1235-2017 The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2015-05-27
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2015-05-27 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of 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... on 2015-05-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1235-2017
Classification: Class II
Status: Terminated
Initiated: 2015-05-27
Posted: 2017-02-22
Terminated: 2017-02-23
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customer Notification Letter/Response Form is being sent to all affected consignees.
Quantity in commerce: 579 units have entered into the distribution chain
Distribution: Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
Product codes and lots: TAOS, TC03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1235-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1235-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-22

Product code KFM

K112229Class IISarn Centrifugal PumpTerumo Cardiovascular Systems / cleared 2011-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)