A recall has been announced for the Penumbra System Reperfusion Catheter 32 due to a manufacturing error, which could cause the devices to fail and lead to life-threatening injury.
The Penumbra Catheter recall was classified on December 8 as a Class I medical device recall by the FDA, meaning that the agency believes the defect is likely to cause severe injury or death. The recall came after reports that the devices are suffering mid-shaft joint failures.
The catheters are used to provide a blood supply to the brain in patients who have experienced a severe stroke. The FDA became aware of the problem after the manufacturer, Penumbra, Inc., sent an Urgent Voluntary Field Removal letter on October 28 to customers, instructing them to inspect their inventory and quarantine it for return to Penumbra. The FDA did not say whether the defective catheters have led to any reported injuries or death.
The recall affects 77 Penumbra System Reperfusion Catheter 032 systems, 28 of which were marketed in the United States. The catheters have a catalog number of PSC032 and a lot number of F15020.
Penumbra employees will contact customers who received the catheters and arrange to have them returned and replaced. Any customers with questions can contact Penumbra at 1-888-272-4606.
Healthcare professionals or consumers who experience a problem with these devices are encouraged to file a report with FDA’s MedWatch adverse event reporting program at www.fda.gov/MedWatch/report.htm.