FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.
- Recall number
- Z-0544-2010
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours.
- Status
- Terminated
- Initiated
- 2009-07-06
- Posted
- 2009-12-17
- Terminated
- 2011-11-09
- Reason
- The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.
- Root cause
- Device Design
- Action
- Terumo Cardiovascular Systems Corporation notified consignees of an "Urgent Medical Device Correction" by letter on July 06, 2009. The letter was addressed to hospital Perfusion, Cardiovascular Surgery, and Operating Room departments and contained specific measures to be taken to ensure proper use of the affected device. The firm recommended that users continue to use the devices and follow the corrective measures enclosed with the notification. Consignees were requested to route the notification to all users and confirm receipt of the notification by returning a customer response form. For further information, contact Terumo CVS Customer Service at 1-800-521-2818.
- Quantity
- 20,702 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Product Number 164275X, Serial Numbers: KP01, KP15, LA05, LA12, LA19, LC02, LC09, LC23, LD02, LD09, LD16, LD30, LE06, LE08, LE13, LE20, LE27, LE29, LF04 and LF07.
- 510(k) numbers
- ["K020998"]
- PMA numbers
- not on file
- Product code
- KFM
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- 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