FDA Issues Class I Product Recall for Medtronic Devices That Could Malfunction
Officials with the Food and Drug Administration on Monday, November 18th, announced a product recall for some Medtronic heart devices that could cause serious injury or even death when they malfunction.
A Class I Recall is the most serious product recall that the FDA can issue, and means that the agency has determined that the product or device can predictably cause serious health problems, side effects, or death.
Medtronic voluntarily issued a product recall on October 21st for its Interventional Wires and ATTAIN HYBRID wires, used in heart surgery, after the company received complaints from four patients, including one patient injury. The FDA investigated the complaints as well, and has now issued its own product recall for the items.
These wires produced by Medtronic are used in heart surgery to guide a catheter into percutaneous coronary interventions, which can open up blood flow with a stent or another device during a heart attack. The reported issue involves coating on the guidewires, which could break off, which can cause a heart attack or stroke because the coating can lead to blood clots or a blocked blood vessel.
Medtronic said that the product recall affected certain lots, which have been manufactured since April of this year. While the FDA issued the Class I recall, Medtronic has contacted regulators around the world to warn them of the problem, and has stopped new shipments of wires until the problem is corrected.
The device manufacturer has a full list of wires under product recall on their website. Concerned patients and consumers can contact the FDA’s MedWatch program either at their website, or by calling 1-800-332-1088.
Defective Product Recalls and Personal Injury in South Carolina
Every year, thousands of consumers sustain serious injuries from defective products, and improper or delayed product recalls. Many of these injuries could be avoided if the manufacturers or distributors of these products took additional steps to ensure consumer safety, such as issuing product recalls in a timely fashion. Although any product could be subject to a recall due to improper testing, some of the most common product recalls are for automobiles and automotive parts, drugs and medical devices, and children’s toys.
There are a number of reasons that defective products make it to our shelves:
- Defective manufacturing
- Inadequate testing
- Design defects
- Marketing Misrepresentation
To protect yourself and your family, it’s important to know what products have been recalled because they are defective or unsafe. Federal agencies such as the FDA (Food and Drug Administration) and the CPSC (U.S. Consumer Product Safety Commission) frequently issue product recalls for medical devices, drugs, and products that may be harmful to consumers.
Consumers that have been harmed by defective products such as drugs, medical devices, or other products, may be eligible to receive legal remedies. Such legal remedies, or damages, may include compensation for medical expenses, lost wages, loss of physical capacity, pain, suffering, and mental anguish. Punitive damages are also available in many jurisdictions to punish defendants in those cases involving particularly egregious conduct which demonstrates a reckless or wanton disregard for the safety of the public.
The Strom Law Firm Protects Citizens Harmed by Delayed Defective Product Recalls
The attorneys at the Strom Law Firm keep a close watch on recalls of dangerous and defective product recalls in the US. We aim to protect our clients’ health and safety, and hold manufacturers to the highest possible standard of safety. If you or a loved one have experienced severe, life-limiting side effects from a defective product or drug, and believe that your pain stems from a product recall that came too late, you may be entitled to compensation. The Strom Law Firm can help. We offer free, confidential consultations to discuss the facts of your case, so contact us today. 803.252.4800.
