Medtronic Issues Precautionary Recall of Heparin-Coated Products

-FDA News

05/13/2008 - Medtronic is recalling certain heparin-coated disposable products used during cardiopulmonary bypass for heart surgeries.

The affected devices have a Carmeda BioActive coating. Limited lots of this coating were manufactured with heparin contaminated with oversulfated chondroitin sulfate (OSCS), the substance found in recalled lots of injectable heparin, Medtronic said.

Affected products include blood oxygenators, reservoirs, pumps, cannulae and tubing packs. Medtronic spokesman Daniel Beach said the company is shipping replacement products with FDA-cleared heparin. Approximately 400 U.S. devices are affected and the recall will have “a very small impact from a financial perspective,” he added.

Medtronic said it has not received reports of any OSCS-related adverse events from the use of Carmeda cardiopulmonary bypass products, but it is unclear if exposure to medical devices coated with comparatively small amounts of heparin could cause events similar to those seen with injectable heparin. 

In a separate action, Medtronic is advising customers that some lots of Trillium-coated products also were manufactured with heparin containing OSCS. Trillium is another biosurface used on cardiopulmonary bypass products. The amount of heparin is significantly lower than that on the Carmeda products, the company said. 

Medtronic said its ultimate goal is to remove contaminated Trillium products from the market, but, based on the current data, the benefit of using the products outweighs any potential risk to patients.