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Home Industry News Medtronic recalls heart surgery products

Medtronic recalls heart surgery products

9th May 2008

Devices used during heart surgery operations have been recalled by manufacturer Medtronic, the company says.

Described as “voluntary and precautionary”, the recall includes disposable items that feature the Carmeda BioActive surface and was prompted by recommendations by the US Food and Drug Administration (FDA).

The FDA told manufacturers that heparin supplies should be checked – after Carmeda-coated products were manufactured with heparin contaminated with oversulfated chondroitin sulfate.

Some reports have found that these heparin-injected products could have caused patient death.

Medtronic’s Trilliun-coated products, which have also been manufactured using heparin, have a minimal risk attached to using them and have not been recalled, the company added.

The company focuses on several medical areas, including cardiac rhythm disease management, neuromodulation, spinal and biologics, diabetes and ear nose and throat.

Its website states: “Every five seconds, somewhere in the world, a person’s life is saved or improved by a Medtronic product or therapy.”

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