A device used to re-establish the blood supply to the brain in patients who are having strokes is being recalled because of a manufacturing error. The recall is classified as a Class 1, which is the most serious type of recall issued by the Food and Drug Administration (FDA) and involves situations in which there is a reasonable probability that the use of these products will cause serious health consequences or death.

The recall involves the Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number F15020. Seventy-seven devices are subject to this recall, of which 22 are marketed within the United States. The defect involves mid-shaft joint failures.

Strokes, or cerebrovascular accidents (CVA), occur when the blood supply to part of the brain is disrupted, causing brain cells to die. As a result of a stroke, the brain is unable to function, leading to the inability to move one or more limbs on one side of the body, inability to understand or formulate speech, or an inability to see one side of the visual field. Strokes are a medical emergency and can cause permanent neurological damage and even death. It is the leading cause of adult disability in the United States and the number two cause of death worldwide. Early recognition and treatment of strokes is considered a key factor in recovery.

Penumbra is instructing customers to inspect their inventory for the affected devices and quarantine them, pending return to the company. Penumbra employees are in the process of contacting customers to arrange return and replacement of affected units. Any side effects with the Reperfusion Catheter 032 should be reported to the FDA MedWatch Adverse Event Reporting System at www.FDA.gov/MedWatch.