November 18, 2013 — At least one person has been injured by defective guidewires used to implant pacemakers, prompting Medtronic and the FDA to issue a class 1 recall. The problem is that the coating on the guidewires can delaminate and detach.
Medtronic product information for the Cougar and Zinger guidewires indicates that they are coated with Hydro-Track, a water-repellent chemical.
Medtronic notified hospitals about the problem on October 21. They have recalled certain lots from several product lines that were manufactured after mid-April 2013. Class 1 recalls are reserved for products that have a reasonable probability of causing patients injuries or death.
Lots have been recalled from the following product lines:
- Cougar nitinol workhorse guidewire
- Cougar steerable guidewire
- Zinger stainless steel workhorse guidewire
- Zinger steerable guidewire
- Thunder extra-support guidewire
- Thunder steerable guidewire
- ProVia crossing guidewire
- Attain Hybrid guide wire
Medtronic has also received reports of other problems with the guidewires. According to this MAUDE adverse event, the tip of a Zinger guidewire detached inside a patient during a procedure. Doctors were forced to leave the tip inside the patient.
Do I have a Medtronic Guidewire Lawsuit?
The Schmidt Firm, PLLC is currently accepting Medtronic guidewire induced injury cases in all 50 states. If you or somebody you know has been injured by a defective guidewire, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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