Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass
No commentsFOR IMMEDIATE RELEASE — MINNEAPOLIS – May 7, 2008 – Medtronic, Inc. today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken subsequent to the U.S. Food and Drug Administration’s April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.
Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. However, the U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS….
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