ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 46
FDA device recall Z-0934-05 · posted 2005-06-25 · Terminated
Recall details
- Recalling firm
- Ev3
- Reason for recall
- A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
- Action taken
- ev3 representative went to the 2 hospitals to retrieve affected product on 06/10/05, completed a Field Action Form and left a copy with the hospital.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 1
- Distribution
- FL and PA
- Date initiated
- 2005-06-10
- Date posted
- 2005-06-25
- Date terminated
- 2005-11-17
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K033314) | Ev3, Inc. | 2003-11-21 |