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U.S. Department of Health and Human Services

Safety

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Penumbra System Reperfusion Catheter 032: Class I Recall Due to Manufacturing Error

[Posted 12/08/2010]

AUDIENCE: Risk Manager, Emergency Medicine

ISSUE: 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.

BACKGROUND: The Penumbra System Reperfusion Catheter 032 is used to re-establish the blood supply to the brain in patients experiencing stroke.

RECOMMENDATION: The company is advising customers to discontinue use of the product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[12/08/2010 - Recall Notice - FDA]