FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022.
- Recall number
- Z-1927-2008
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers: CB81120 and CB87022.
- Status
- Terminated
- Initiated
- 2008-05-09
- Posted
- 2008-07-24
- Terminated
- 2012-05-08
- Reason
- Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).
- Root cause
- Nonconforming Material/Component
- Action
- Medtronic issued a Press Release on 05/07/2008. An Urgent Medical Device Recall letter was sent to customers on May 07, 2008. The letter identifies affected devices, explains the situation and requests that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall Certificate acknowledging the receipt of this information.
- Quantity
- 29 US, 1 OUS
- Distribution
- Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.
- Lot, serial or model codes
- Catalog / Lot: CB81120 / 9890943 , CB87022 / 9816224
- 510(k) numbers
- ["K840002"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- 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