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.
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