ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainle
FDA device recall Z-0912-06 · posted 2006-05-31 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.
- Action taken
- ev3 field representatives visited all affected accounts. Product was retrieved a 'Field Action Form' was completed and a copy was left with the account.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 29
- Distribution
- Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV
- Date initiated
- 2006-03-08
- Date posted
- 2006-05-31
- Date terminated
- 2007-02-03
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMUS STENT AND DELIVERY SYSTEM (K043243) | Ev3, Inc. | 2004-12-09 |