Medtronic, Inc., in what is termed a precautionary measure, has voluntary recalled selected products featuring its Carmeda BioActive surface, a coating applied to some devices used in heart bypass surgery and dialysis, because the coating includes contaminated heparin, a blood thinner that has been linked to 81 deaths. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.
This action was 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.
The FDA has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS such as patients undergoing heart surgery or dialysis. Medtronic has not received reports of any OSCS-related adverse events arising from the use of Carmeda CPB products.
In a separate action, Medtronic is advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products. But because the amount of heparin on the product is significantly lower than that contained on the Carmeda product, trillium coated products are not being recalled. The actions were made with the knowledge of the FDA.
Patients with questions should talk to their physician. Physicians or Pefusionists with medical questions related to Medtronic therapies should contact Medtronic at 1-800-638 0218, Monday Friday, 8:00 a.m. to 5:00 p.m. CDT.
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