Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This product is only available OUS. Catalog

FDA device recall Z-1930-2008 · posted 2008-07-24 · Terminated

Recall details

Recalling firm

Medtronic Perfusion Systems

Reason for recall

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).

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DWF

Quantity affected

28 OUS

Distribution

Worldwide Distribution: USA, Australia, Belgium, Canada, Czech Republic, France, Italy, Japan, Norway, and Taiwan.

Date initiated

2008-05-09

Date posted

2008-07-24

Date terminated

2012-05-08

Location

Brooklyn Park, MN