Medtronic has initiated a voluntary and precautionary recall of selected disposable products featuring the Carmeda BioActive surface that are used during cardiopulmonary bypass (CPB) for heart surgeries.
The affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs, according to the Minneapolis-based Medtronic.
The company said its action is subsequent to the FDA’s April 8 recommendation to device manufacturers that heparin supplies be checked with newly developed tests, and that affected products be evaluated for possible field corrective action.
Medtronic said limited lots of its Carmeda-coated products manufactured with heparin were 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 unknown at this time, according to the company. However, the FDA has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS.
The company has not received reports of any OSCS-related adverse events arising from the use of Carmeda CPB products, yet, it is unclear if exposure to Carmeda-coated medical devices, made with small amounts of heparin, could cause adverse events similar to those observed with injectable heparin formulations.