FDA Reissues Eon and Eon Mini IPG Recall
The U.S. Food and Drug Administration recently reissued a recall for the St. Jude Medical Eon and Eon Mini Implantable Pulse Generator (IPG) after reports of battery failure and burn injuries.
Details of the Eon and Eon Mini IPG Recall
- The FDA has classified the IPG recall as a Class II recall.
- Recalled IPG models:
- Eon (65-3716)
- Eon Mini (65-3788)
- The recall applies to all 70,638 distributed units of Eon and Eon Mini IPG.
- There have been reports of the IPG device batteries failing to hold a charge, losing power unexpectedly, and overheating causing burn injuries.
- As of 2012, the FDA had received 325 reports of battery issues in the IPG with 72 of those resulting in device removal.
Injuries and Complications Associated with the Eon and Eon Mini IPG
- 1st Degree Burns
- 2nd Degree Burns
- Device Removal (Explant Surgery)
- Complications with Anesthesia
Contact an Experienced Product Liability Attorney
Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or medical devices, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.