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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 Retrieversee related information
Date Initiated by FirmSeptember 24, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on December 04, 2003
Recall NumberZ-0085-04
Recall Event ID 27491
510(K)NumberK003410 K030476 
Product Classification Catheter, Percutaneous - Product Code DQY
ProductConcentric 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 ContactMatthew Shonk
651-575 Ext. 6171
Manufacturer Reason
for Recall		The device has the potential for tip breakage during use.
FDA Determined
Cause 2		Other
ActionOn 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 Commerce97 units
Distribution7 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 CycleTPLC 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) Database510(K)s with Product Code = DQY
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