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.
FDA MedWatch Safety Alert. Penumbra System Reperfusion Catheter 032: Class I Recall Due to Manufacturing Error. December 8, 2010.