December 14, 2010 – Penumbra, in cooperation with the U.S. Food and Drug Administration (FDA), has initiated a voluntary safety recall of the Penumbra System Reperfusion Catheter 032. The function of the Penumbra System Reperfusion Catheter 032 is to re-establish the blood supply to the brain following a stroke. The catheter is almost always used in a hospital setting, therefore hospital risk managers are strongly urged to comply with this recall. The recall has been initiated because of a malfunction of the catheter’s mid-shaft joint. The mid-shaft joint can fail, impeding the catheter’s ability to resupply blood to the brain. This poses a risk of serious adverse health effects or even death to the patient.
This recall affects the Penumbra System Reperfusion Catheters 032 from the lot number F15020. Penumbra and the FDA have advised customers to cease use of the defective catheters immediately. Further use of the defective catheters is an unnecessary risk involving the lives of patients. Both healthcare professionals and patients, or families of patients with incidents or adverse side effects related to the defective catheters are advised to contact the FDA’s Medwatch Safety Information and Adverse Event Reporting Program. The defective catheters should be immediately discarded or returned to Penumbra.
Contacting a New York Product Liability Lawyer
When you have sustained a serious injury or lost a loved one because of another’s negligence you are entitled to seek compensation for your damages and suffering. Consulting with a New York product liability lawyer can help you better understand your rights, determine liability for your injuries and decide if filing a product liability claim is right for you. At Gacovino Lake & Associates we have formed a dedicated network of product liability lawyers that serve clients nationwide. Our New York office serves residents of the 5 boroughs with their auto accident, medical malpractice, defective drug, premises liability and Workers’ Compensation claims. For experienced help with your product liability claim, contact us today – 1-800-246-4878.
