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U.S. Department of Health and Human Services

Class 2 Device Recall Concentric Retriever

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  Class 2 Device Recall Concentric Retriever see related information
Date Initiated by Firm September 24, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on December 04, 2003
Recall Number Z-0085-04
Recall Event ID 27491
510(K)Number K003410  K030476  
Product Classification Catheter, Percutaneous - Product Code DQY
Product Concentric brand Concentric Retriever¿ X5 Percutaneous Catheter Model REF 90035
Code Information Lot numbers: 31494 or lower
Recalling Firm/
Manufacturer		 Concentric Medical Inc
1380 Shore Bird Way
Mountain View CA 94043-1338
For Additional Information Contact Matthew Shonk
651-575 Ext. 6171
Manufacturer Reason
for Recall		 The device has the potential for tip breakage during use.
FDA Determined
Cause 2		 Other
Action On 09/24/03, the firm issued letters and follow-up letters on 10/17/03 via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
Quantity in Commerce 97 units
Distribution 7 consignees in the US were shipped Concentric Retriever X5 or Concentric Retriever X6 devices with lot number 31494 or lower. A total of 97 units affected were released for US distribution. Distribution was limited to 6 States: MA, GA, NY, OH, MO and CA. The recall was appropriately extended to the user level; i.e., the hospitals which received the recalled products. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
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 = CONCENTRIC MEDICAL, INC.
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