FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
- Recall number
- Z-2029-2014
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
- Status
- Terminated
- Initiated
- 2014-04-14
- Posted
- 2014-07-11
- Terminated
- 2016-09-07
- Reason
- During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- not on file
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot No. RC07, QM03, QN07, and RA09.
- 510(k) numbers
- ["K112229"]
- PMA numbers
- not on file
- Product code
- KFM
- Firm FEI
- 3000204839
- Firm city
- Elkton
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28