Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037
FDA device recall Z-0086-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Concentric Medical Inc
- Reason for recall
- The device has the potential for tip breakage during use.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQY
- 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. Distribut
- Date initiated
- 2003-09-24
- Date posted
- 2004-07-20
- Date terminated
- 2003-12-04
- Location
- Mountain View, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 (K030476) | Concentric Medical, Inc. | 2003-03-11 |