The FDA said the affected devices are disposable products used during cardiopulmonary bypass heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae and tubing packs. This action follows the FDA's April recommendation to device manufacturers that heparin supplies be checked with newly developed tests.

The agency said limited lots of Carmeda-coated products manufactured with heparin have been found to have been contaminated with oversulfated chondroitin sulfate. The patient risk associated with OSCS in heparin-coated medical devices isn't known but the Food and Drug Administration said it's received reports of serious injury and death in patients administered injectable heparin products containing high levels of OSCS.

In a separate action, Medtronic is advising its customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used in products during cardiopulmonary bypass heart surgery, although the amount of heparin on trillium is significantly lower than that contained on the Carmeda product, Medtronic said.