The Sarns Centrifugal Pump is a single use device… recallZ-1235-2017 · Terumo Cardiovascular Systems Corporation · initiated May 27, 2015
Class II Terminated All recalls posted in February 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Terumo Cardiovascular Systems Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Customer Notification Letter/Response Form is being sent to all affected consignees.
Recall details
- Recall number
- Z-1235-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 27, 2015
- Posted by the FDA
- Feb 22, 2017
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 579 units have entered into the distribution chain
- Product code
- KFM
- FDA submissions
- K112229
- Distribution
- Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
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.
Code information (models, lots, serial numbers)
TAOS, TC03
Other devices under the same FDA submission
4 devices cleared under K112229 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Sarns™ Centrifugal Pump without X-Coating™ 164275Terumo Cardiovascular Systems Corporation · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type1 death15 reports
- Sarns™ Centrifugal Pump Adapter 824043Terumo Cardiovascular Systems Corporation · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type13 reports
- Sarns™ Centrifugal Pump with X-Coating™ 164275XTerumo Cardiovascular Systems Corporation · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type10 reports
- Sarns™ Centrifugal Pump with X-Coating™ CV-164275XTerumo Cardiovascular Systems Corporation · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page