In December, the U.S. Food and Drug Administration (FDA) announced a recall of certain guidewires made by Medtronic, Inc. Patient complication reports were reported to the FDA and the company concerning the coating on the wire’s surface that had the potential to detach and delaminate. Medtronic began notifying hospitals and distributors after it received a number of reports of complaints including one patient injury. The company requests that all affected lots be quarantined and returned to Medtronic for credit and replacement. There could be nearly 15,000 guidewires affected that were made after April 2013.
Guidewires are long, thin wires used in coronary intervention to guide the placement of left ventricular leads that attach to cardiac rhythm devices. The defective coating is made of a Teflon product called PTFE or polytetrafluroethylene. Teflon is the same material used to make non-stick cookware.
When the surface of the guidewire detaches or delaminates inside a patient it can travel and cause stroke, heart attack or blood clots, among other complications.
Medtronics, based in Minneapolis, is one of the world’s largest medical device makers.
The company makes a variety of guidewires by different names.
- Cougar steerable guidewire
- Cougar nitinol workhorse guidewire
- Zinger stainless steel workhorse guidewire
- Zinger steerable guidewire
- Thunder extra-support guidewire
- Thunder steerable guidewire
- ProVia crossing guidewire
- Attain Hybrid guide wire
The recall is considered the most serious by the FDA and so is called Class I. That means it has the potential to cause serious health complications or could be fatal. The FDA cannot order a recall so the company must do so voluntarily at the urging of the agency.
Medtronic has been in the headlines recently.
Last year a Senate Finance Committee found Medtronic paid hundreds of millions of dollars to doctors who would ghost-write medical papers promoting the use of Medtronic’s InFuse bone-growth product, a genetically engineered protein used to stimulate bone growth in degenerating discs. The 13 overwhelmingly positive articles consistently downplayed the risks of the InFuse bone graft, the company’s $800 million a year blockbuster bestseller and omitted dangers of male sterility, infection, an increased risk of cancer, bone dissolution, and leg and back pain.