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FDA Warning: Medical Device Coatings Linked to 9 Deaths

November 23, 2015 — At least nine deaths and hundreds of adverse events have been blamed on special coatings that peel off instead of helping medical devices slide inside blood vessels, according to a Safety Communication from the FDA.

The problem is that the coatings may separate (e.g., peel, flake, shed, delaminate, slough off) and cause severe injuries like pulmonary embolism, heart attack, stroke, tissue necrosis, or death.

The coatings include silicone, polyvinylpyrrolidone (PVP), and polytetrafluoroethylene (PTFE). They have been used for more than 20 years on devices like cardiac guide-wires, sheaths, retrieval devices, and more.

Since the beginning of 2010, various manufacturers have issued 11 recalls due to the problem. About 500 adverse events have been filed with the FDA since January 2014, including nine people who died during heart or brain catheterization.

The agency did not name any specific products or manufacturers and said many factors can contribute to the problem. These factors include difficult procedures, technique, improper storage or pre-conditioning, defective design, manufacturing issues, and more.

According to the FDA:

“Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, health care providers should be aware of potential problems and consider certain actions prior to use.”

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