Recall Z-0086-04 ยท DQY Catheter, Percutaneous
Concentric Medical Inc
Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037
| Date | Jul 20, 2004 (initiated Sep 24, 2003) |
| Status | Terminated |
| Reason | The device has the potential for tip breakage during use. |
| Root cause | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030476 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 Concentric Medical, Inc., Mar 11, 2003 |