Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035
FDA Recall Z-0085-04 · Posted 2004-07-20
Recalling FirmConcentric Medical Inc
Recall StatusTerminated
Product CodeDQY
Date Initiated2003-09-24
Date Terminated2003-12-04
Product Quantity97 units
Reason for Recall
The device has the potential for tip breakage during use.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.