Medtronic (Minneapolis) said it is pulling some of its disposable heart surgery products because of concerns about a coating of contaminated heparin. The company termed it a "voluntary and precautionary recall."

Included in the recall are disposable products with the Carmeda BioActive surface that are used during cardiopulmonary bypass (CPB) for heart surgeries.

Medtronic said some of its Carmeda-coated devices were made with heparin contaminated with oversulfated chondroitin sulfate (OSCS). The coating is used on blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.

Daniel Beach, a Medtronic spokesman, told Medical Device Daily the recall is relatively small.

"We estimate in the U.S. there are fewer than 400 of these products on the shelves," Beach said, adding that the devices run between $200 and $500 each.

Medtronic said the recall is in response to FDA's April 8 recommendation that heparin supplies be checked with newly-developed tests and that affected products be evaluated for possible field corrective action.

The patient risk associated with OSCS in heparin-coated devices is not known, the company said, but the recall follows reports of death and serious illness in patients who have been given injectable heparin products containing high levels of OSCS. According to FDA, at least 81 people in the U.S. given heparin have died since January 2007 after suffering allergic reactions (Medical Device Daily, April 24, 2008).

FDA said it didn't inspect a plant in China that made the main ingredient in Baxter International's (Deerfield, Illinois) blood-thinner heparin, which was contaminated. The agency said it confused records on that facility and another with a similar name. Baxter and its supplier say the contaminant must have been added earlier in the supply chain, before the products reached their facilities.

Medtronic said it has not received reports of any OSCS-related adverse events related to 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, the company noted.

In addition to the recall, Medtronic is warning customers that some of its Trillum-coated products were also made with heparin containing OSCS. Trillum is another biosurface used on CPB products. The amount of heparin on it is "significantly lower" than that contained on Carmeda-coated products, the company said.

Medtronic said it wants to remove contaminated products from the market but that, based on current data, the benefit of using the affected products outweighs any potential risk to patients.

According to the company the maximum possible patient exposure to heparin from Trillum is "extremely low," so customers can continue to use the affected Trillum products until a replacement is available.

After initially recalling nine lots of heparin sodium injection multi-dose vials on Jan. 17, Baxter proceeded to recall all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products (MDD, March 3, 2008).

Due to the widespread use of the blood thinner and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, FDA and Baxter said that removing additional lots and doses of the product from the market earlier would have created more risk to patients requiring heparin therapy than the increased potential for illness or death.

Nearly all reported adverse reactions have occurred in three areas of use — renal dialysis, invasive cardiovascular procedures and apheresis procedures. Patients who have experienced adverse reactions have reported everything from stomach pain or discomfort to dizziness and fainting.

Citing deaths and allergic reactions linked to contaminated versions of heparin from China, lawmakers last month said FDA must conduct more inspections of companies sending drugs to the U.S. to ensure they are safe.