Penumbra System Reperfusion Catheter 032: Class I Recall Due to Manufacturing Error
MedSun: Newsletter #56, January 2011

FDA MedWatch Safety Alert

FDA and Penumbra notified healthcare professionals of a Class I recall due to a manufacturing error. Mid-shaft joint failures were occurring in some Reperfusion Catheters 032 produced from lot F15020. The company is advising customers to discontinue use of the product.

Additional Information:

FDA MedWatch Safety Alert. Penumbra System Reperfusion Catheter 032: Class I Recall Due to Manufacturing Error. December 8, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm236155.htm