Medtronic Initiates Voluntary Recall of Selected Heparin-Coated Cardiopulmonary Bypass Products
Medtronic has announced that it is initiating a voluntary recall of selected disposable products used during cardiopulmonary bypass which feature the Carmeda BioActive surface, according to Medtronic and the FDA.
The affected products include blood oxygenators, reservoirs, pumps, cannulae and tubing packs.
The recall was initiated after a limited number of lots of Carmeda-coated products, manufactured with heparin, were found to have been contaminated with oversulfated chondroitin sulfate. The patient risk associated with the presence of the sulfate in heparin-coated medical devices is unknown at this time, but the FDA has received reports of serious injury and death in patients who administered injectable heparin products containing high levels of the sulfate.
Read more about the voluntary Medtronic recall.
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