FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE
- Recall number
- Z-0054-2012
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE
- Status
- Terminated
- Initiated
- 2011-09-13
- Posted
- 2011-10-17
- Terminated
- 2012-12-10
- Reason
- Terumo Cardiovascular Systems (Terumo CVS) recently discovered three instances of metal fragments inside the stainless steel tube of the Sarns" Adult Rigid Intracardiac Sucker.
- Root cause
- Nonconforming Material/Component
- Action
- On 9/13/2011 Terumo sent a letter entitled "URGENT MEDICAL DEVICE REMOVAL" to its customers that included the name and description of the device, lot numbers, the potential hazard, correction, the reason for the recall and instructions. Customers are to review the notice, ensure that all users are aware of the issue, and a recall response form to be completed and returned. Customers are to call Terumo CVS Customer Service to obtain a Return Goods Authorization number. The letter also included MedWatch reporting information and stated that Customers with questions should call 1-800-521-2818.
- Quantity
- 5700
- Distribution
- Worldwide Distribution -- USA, Belgium, Australia, Mexico, and Japan.
- Lot, serial or model codes
- Catalog number 11009010
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DTS
- 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