*Another* Class 1 Recall: What’s going on with PTFE coating?

alertFor the second time in as many weeks, a manufacturer is issuing a Class 1 recall  — the most serious kind — for a guidewire product coated in a substance called PTFE. On November 22, the maker of the FindrWIRZ Guidewire system (SentreHeart) recalled its product because the wire’s PTFE coating could flake off during procedures, causing a danger of deadly clots.  Now, another manufacturer — Medtronic — is recalling its aneurysm treatment system for the same reason.  According to Medtronic’s press release, the recall affects 84,278 units worldwide made between July 2014 to September 2016. The list of affected lots is here.

How to protect yourself? If you are having any surgical procedure, ask your doctor if any sort of guidewire is going to be used. If it is, ask the doctor to call the manufacturer to confirm the guidewire does not have PTFE coating.  To see the recall notice, click here or the picture below:


And if you’ve been injured in surgery involving a PTFE coated product, click here to talk to an advocate.

Peter Mullenix