November 18, 2013 — Medtronic Inc. and the U.S. Food and Drug Administration (FDA) have announced a Class 1 recall of the guidewires used during pacemaker implantation. The problem is that the coating on the guidewires can delaminate and detach.
According to product information for the Cougar guidewire, the coating is a water-repellent material called Hydro-Track.
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 began notifying hospitals about problems with the guidewires on October 21. They warned that some lots manufactured after mid-April 2013 could be defective. The company has received one report of a patient who was injured.
In addition, according to this MAUDE adverse event, there was an incident in which the tip of the Zinger guidewire detached inside a patient. Doctors were unable to safely remove the tip, and so they left it inside the patient.
Need a Texas Medtronic Guidewire Lawyer?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact our Texas medical device lawyers for a free lawsuit review.