Sarns Disposable Centrifugal Pump with X-Coating, 164275X… recallZ-2029-2014 · Terumo Cardiovascular Systems Corporation · initiated Apr 14, 2014
Class II Terminated All recalls posted in July 2014
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
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
FDA root cause category: Device Design
What the company is doing
Urgent Medical Device Recall letters, dated April 11, 2014, were sent to customers. The letters identified the affected product, as well as the reason for the correction, the potential hazard, the correction, the affected population, and instructions for customers. Customers are to review the notice and ensure that all users have received a copy. Additionally, customers are to confirm receipt of the communication by returning the attached Customer Response Form as instructed; and, return all effected centrifugal pumps. Terumo CVS will issue a Returned Goods Authorization upon receipt of the Response Form. Questions should be directed to Terumo CVS Customer Service at 800-521-2818.
Recall details
- Recall number
- Z-2029-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 14, 2014
- Posted by the FDA
- Jul 11, 2014
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product code
- KFM
- FDA submissions
- K112229
- Distribution
- Nationwide Distribution
Product description
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Code information (models, lots, serial numbers)
Lot No. RC07, QM03, QN07, and RA09.
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
Other products in the same recall event
The FDA groups related products into one recall event (event 68024).
- Z-2028-2014 · TerminatedSarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
- Z-2030-2014 · TerminatedCardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 7…
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.
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