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U.S. Department of Health and Human Services

Class 2 Device Recall Codman (and Formerly MICRUS) NEUROPATH

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  Class 2 Device Recall Codman (and Formerly MICRUS) NEUROPATH see related information
Date Initiated by Firm January 11, 2013
Date Posted February 20, 2013
Recall Status1 Terminated 3 on August 10, 2015
Recall Number Z-0857-2013
Recall Event ID 64158
510(K)Number K052004  
Product Classification Catheter, percutaneous - Product Code DQY
Product NEUROPATH 5Fx90 GUIDING CATH MPD
Product Code: GMD50900000

Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Code Information All unexpired lots
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information Contact
508-880-8100
Manufacturer Reason
for Recall		 Sterility of device may be compromised due to lack of package integrity
FDA Determined
Cause 2		 Component design/selection
Action Codman sent an Urgent Voluntary Product Recall Notification letter dated January 11, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to check all inventory to determine if they have any affected product, use the included instructions to report inventory status, return and obtain replacement product. Customers were instructed to contact your local Codman Representative or Stericycle at 1-866-201-9077. For questions regarding this recall call 508-880-8100.
Quantity in Commerce 202 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovakia, Spain, and Switzerland.
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 = DQY and Original Applicant = VASCON LLC
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