Z-1235-2017 Class II Terminated
FDA device recall Z-1235-2017 was initiated by Terumo Cardiovascular Systems Corporation on May 27, 2015 and is designated Class II. 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… The recall status is terminated (terminated Feb 23, 2017). Affected quantity: 579 units have entered into the distribution chain.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 1, 2017
- Initiation Date
- May 27, 2015
- Termination Date
- Feb 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 579 units have entered into the distribution chain
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.
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.
Distribution Pattern
Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
Code Information
TAOS, TC03
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1235-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026