A Class I Medtronic Catheter recall has been mandated by the U.S. Food and Drug Administration following a series of disturbing complaints about the 6 French Sherpa NX Active Guide series of cardiac catheters.
Explaining the Medtronic Catheter Recall
The FDA released the class I Medtronic catheter recall on October 8th, 2019. The class I is the most severe recall the FDA has the authority to issue and is only given to products who pose a serious and immediate danger to consumers. The Medtronic catheter recall affects all models of the 6 French Sherpa NX Active Guide Catheters manufactured and distributed between March 10, 2017, and April 4, 2019. According to official inventory counts, the Medtronic catheter recall affects 106, 298 devices across the United States.
The intended use of the 6 French Sherpa NX Active Guide Catheters was to access veins and arteries inside or around the heart, known as the coronary and peripheral vascular systems. The 6 French Sherpa NX Active Guide was often used to facilitate the placement and exchange of guidewires and other devices intended for interventions as well as administer drugs or fluids to blood vessels.
The reason for the Medtronic catheter recall comes from the risk of the outer material on the catheters separating from the device, exposing the underlying stainless-steel braid wires and detaching fragments of covering into the body. Once these fragments detach, they enter the patient’s bloodstream where they can cause serious damage, as could attempts to remove the fragments. Some of those potential injuries include:
- Continued blockage of blood vessels
- Injury to blood vessel walls
- Development of blood clots
- Development of embolisms
- Heart attack
- Death.
Five customer complaints were received about these potentials before the FDA issued the Medtronic catheter recall. No serious injuries or deaths have yet been reported.
On June 15, 2019, Medtronic sent a Revised Urgent Medical Device Recall Notice to hospitals and physicians requesting that they identify and remove any product affected by the recall and that they return the product to Medtronic.
The number of received devices has not been published, but the FDA and Medtronic continue to encourage the return of the faulty catheters.
How the Medtronic Catheter Recall Affects Your Compensation
The FDA and Medtronic are working to attempt to limit the number of future injuries by issuing the Medtronic catheter recall, but there have already been patients affected by this faulty device. If you or a loved one have been injured, hospitalized, or suffered wrongful death after undergoing an operation that used the 6 French Sherpa NX Active Guide Catheter, you may be entitled to financial compensation. In order to recover that compensation, however, you will need exceptional legal expertise. That expertise can be found at Parker Waichman LLP.
At Parker Waichman LLP, teams of experienced lawyers are prepared to pursue your case to its fullest extent to recover the compensation that you deserve. With proven expertise in pursuing defective medical device cases, Parker Waichman is the easy choice. Don’t wait. Contact Parker Waichman today or a free consultation and begin your journey towards justice.
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