Medtronic recalls heparin-coated heart bypass medical devices

Adverse Event Reporting News, May 20, 2008

Medtronic May 14 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, FDA stated on its Web site.

This action is being taken subsequent to 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, the agency added.

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 agency has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS.

Medtronic has not received reports of any OSCS-related adverse events arising from the use of Carmeda CPB products. It is unclear, however, if exposure to Carmeda-coated medical devices, made with comparatively small amounts of heparin, could cause adverse events similar to those observed with injectable heparin formulations. As a result, Medtronic has initiated a precautionary recall of affected Carmeda products, FDA stated.

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. The amount of heparin on the product is significantly lower than that contained on the Carmeda product. Medtronic's ultimate goal is to remove contaminated products from the market.

However, based on the current data, the benefit of using the affected products outweighs any potential risk to patients. Since the maximum possible patient exposure to heparin from Trillium is extremely low, customers can continue to use the affected Trillium products until a replacement is available, FDA concluded.