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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Terumo Cardiovascular Systems Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
Terumo Cardiovascular Systems Corporation is recalling Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and conve due to The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026