May 3, 2011 - A class 1 recall has been issued for the Penumbra Coil 400 system used in patients suffering from brain aneurysms to help prevent blood vessel rupture or leakage.
On March 4th 267 affected lots were recalled by the FDA and Penumbra, Inc. to prevent patient injury and death from use of the defective medical devices. The device's delivery tool has a pull wire that can slip out during implantation, allowing premature detachment of the coil. This error can cause the coil to migrate, leading to blood clots, stroke, and other serious injury.
Since the recall, the affected lots F17211 - F18553 have all been accounted for and returned to Penumbra Inc. This was done through the FDA announcement, as well as direct contact from the company to the customers and distributors in the form of a letter with return instructions.
A class 1 recall by the FDA is the most serious type of recall of defective medical devices. This class of recall means there is a high probability that use of the defective device will cause serious injury or death to a patient. Retailers and medical professionals who receive notice of a class 1 recall on a medical device must act quickly to inform patients who already have the device to stop use immediately. Sales and distribution of the devices must also be discontinued as soon as the recall is announced.
If you or a loved one has suffered serious injury or death from a defective medical device you should contact a St. Louis defective product attorney immediately to discuss your case. Medical device companies must be diligent in assuring the products they produce to help our health and well being do not do more harm than good to patients who use them.
Contacting a St. Louis Defective Product Attorney
When a defective product causes serious injury or death, the liable party needs to be held accountable for their negligence. Filing a Missouri product liability claim is no easy feat, but with the help of a St. Louis defective product attorney, you can feel confident knowing your case is in good hands, while you focus on your recovery and getting your life back on track. To get started with determining if you have a viable defective product case, contact the Missouri product liability team at Bollwerk & Tatlow, LLC - 314-315-8111.
Posted on May 05, 2011