Medtronic Perfusion Systems Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This product is only available OUS. Catalog number: M470450E Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This product is only available OUS. Catalog number: M470450E
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
Catalog / Lot: M470450E / 200968580
Products Sold
Catalog / Lot: M470450E / 200968580
Medtronic Perfusion Systems is recalling Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This product is only due to Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
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