Class I Recall of Stroke Catheter (Penumbra System Reperfusion Catheter 032)

• Date: December 16, 2010
• Source: Admin

A stroke is a rapidly developing loss of brain function occasioned by interrupted blood supply to the brain. As a result, the affected area of the brain is unable to function. A stroke is a medical emergency and can cause permanent damage.

Why the recall?

The recall was issued because mid-shaft joint failures were noticed in some Reperfusion Catheters 032, belonging to lot F15020.  Such defective devices may prevent the flow of blood to the brain causing serious injury to or death of patients. The recall applied to 77 devices of which 28 were sold in the U.S. Healthcare professionals and costumers in possession of the recalled device were advised to discontinue its use.

Regulations

The FDA has jurisdiction over food, drugs, cosmetics, medical devices and other products and monitors product recalls. In most cases, recalls are voluntarily initiated by the manufacturer, when the manufacturer discovers that it is defective. In others, the FDA will notify the manufacturer of the defective product and suggest a recall.

FDA guidelines categorize all recalls into one of the following three classes according to the hazard level:
 

• Class I recalls for dangerous or defective products that could cause serious health problems or death.
• Class II recalls for products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
• Class III recalls for products that are unlikely to cause any adverse health reaction, but violate FDA regulations.