Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035
- Company
- Concentric Medical Inc
- Recall Initiated
- September 24, 2003
- Posted
- July 20, 2004
- Terminated
- December 4, 2003
- Recall Number
- Z-0085-04
- Quantity
- 97 units
- Firm Location
- Mountain View, CA
Reason for Recall
The device has the potential for tip breakage during use.
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.
Lot / Code Info
Lot numbers: 31494 or lower
Root Cause
Other
Action Taken
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.
More recalls by Concentric Medical Inc
Distal Access Catheters - 044 - 115 cm:
Finished Good Number 90960-001 / REF 90960.
Cardiology: The...
Oct 9, 2015
Distal Access Catheter:
Model Numbers: 90121, 90130, 90131, 90160.
The Distal Access Catheter is in...
Dec 12, 2014
Trevo Pro 4 Stent Retriever,
Model number 80021;
U.S. Indications for use: The Trevo Retriever is in...
Dec 8, 2014