Personal Injury Law

Medtronic recalls Heparin CardiopulmonaryProducts

By Brian F. LaBovick, Esq.

Medtronic, Inc. voluntarily recalled several Heparin products, According to the U.S. Food and Drug Administration (FDA). One can only wonder what took them so long to get this conviction. On April 8, 2008, the U.S. Food and Drug Administration's recommended that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action. The Medtronic recalled products include disposables used for heart surgeries and the cardiopulmonary bypass, including reservoirs, blood oxygenators, tubing packs, and pumps. It is unclear if exposure to Heparin Carmeda-coated medical devices could cause adverse events similar to those observed with injectable heparin formulations.

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 ultimate goal is to remove all contaminated products from the market.

The Medtronic recall is a precautionary one. Let's all hope the company continues to take measures regarding their products that will help save lives and not threaten them.

Full post as published by LaBovick Injury Law Blog on May 16, 2008 (boomark / email).