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Medtronic Recall of Heparin-Coated Products Used in Cardiopulmonary Bypass Surgery

Contaminated Heparin Products Cause Injury and Death
Our law firm is investigating several cases involving heparin. 81 people may have died and over 700 other people may have been seriously injured by heparin products. Prompted by adverse reactions suffered by patients given Baxter heparin products, the company initiated a recall. Baxter's heparin recall initially involved 14 lots of heparin products. The heparin recall was expanded on February 28 to include all of Baxter Healthcare's multi-dose and single-use vials of heparin sodium for injection, and their heparin lock flush solutions. read about the Baxter heparin recall and a Baxter heparin lawsuit.

The information below regards a recall of Medtronic's heparin products used for cardiopulmonary bypass surgery. These products included As stated above, there has also been a Baxter heparin recall. Please contact our lawyers if you have been injured by heparin. If you know what heparin product may have been the cause of the injury, please let us know.

Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery

May 7, 2008 – Medtronic, Inc. has recalled selected products featuring the Carmeda BioActive surface, which uses heparin. The heparin may be contaminated with oversulfated chondroitin sulfate (OSCS), a heparin-like compound that can cause death or other serious adverse events.

The recalled Medtronic devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.

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 U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS. Over 80 deaths and 700 serious adverse events have been associated with Baxter heparin products and other heparin products. 

In this case, there have not been any deaths or adverse events associated with Medtronic's recalled products that use heparin.  This may be because Medtronic's recalled products do not contain high levels of heparin.  Even so, there still exists a potential exposure of OSCS to the patient.

Medtronic has also taken a separate action with regards to its Trillium-coated products:

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.

If you have an adverse reaction to any Medtronic product, please contact us at 1-888-377-8900 (toll-free). You may also e-mail our lawyers or submit our free case consultation form.

 


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