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U.S. Department of Health and Human Services

Class 1 Device Recall Penumbra System Reperfusion Catheter 032

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  Class 1 Device Recall Penumbra System Reperfusion Catheter 032 see related information
Date Initiated by Firm October 25, 2010
Date Posted November 24, 2010
Recall Status1 Terminated 3 on June 01, 2011
Recall Number Z-0428-2011
Recall Event ID 57166
510(K)Number K072718  
Product Classification Catheter, thrombus retriever - Product Code NRY
Product Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.
Code Information Lot number F15020
Recalling Firm/
Manufacturer		 Penumbra Inc.
1351 Harbor Bay Pkwy
Alameda CA 94502-6541
For Additional Information Contact
510-748-3200
Manufacturer Reason
for Recall		 Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment.
FDA Determined
Cause 2		 Process control
Action Penumbra issued an Urgent Voluntary Field Removal letter dated October 28, 2010 to consignees, identifying the affected device and actions to be taken by consignees. Customers were instructed to inspect their inventory for the affected product and quarantine it, pending return to Penumbra. Penumbra employees will contact customers to arrange return and replacement of affected units. Customers were also requested to complete and return a product identification form and return form to Penumbra within 5 business days. Customers can contact Penumbra at 1 510 748-3223 concerning this action.
Quantity in Commerce 61
Distribution Worldwide Distribution: 17 consignees in the US, including in the states of CA, FL, HI, ID, IL, KY, MA, MS, NJ, NY, PA, and TX, 1 in Canada and 21 in the EU countries of France, Germany, Hungary, Italy, Norway, Slovenia, Spain, and the United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NRY and Original Applicant = PENUMBRA, INC.
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