FDA Device recall Z-1235-2017
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas
- FDA Device
- Class II
- terminated
- Published 2017-03-01
On 2017-03-01 the FDA classified a Class II recall of The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas by Terumo Cardiovascular Systems, citing terumo Cardiovascular Systems Corporation has received complaints indicating that the Sarns Centrifugal Pump (disposable pump heads) have exhibited leaks. The leaks were detected….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1235-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-27 |
| Published | 2017-03-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | n/a |
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.
Reason
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.
Identifiers
| code_info | TAOS, TC03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1235-2017%22
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