ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
FDA device recall Z-0389-2007 · posted 2007-02-01 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected.
- Action taken
- Letter 12/06/2006. An ev3 representative visited the affected hospital to determine the status of the recalled device. If the device is unused, the representative is to retrieve the device for return to ev3. The representative is to complete the Device Recall Field Action Form, along with a hospital representative signature, and fax the completed form to ev3.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 2
- Distribution
- IL, PA
- Date initiated
- 2006-12-06
- Date posted
- 2007-02-01
- Date terminated
- 2007-02-03
- 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 |