ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-
FDA device recall Z-1548-2008 · posted 2008-09-26 · Terminated
Recall details
- Recalling firm
- Ev3, Inc
- Reason for recall
- ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended.
- Action taken
- Consignees were sent a "Medical Device Recall" letter dated 7/1/08. The letter described the product, problem and action to be taken. The letter also requested to complete and return The Field Action Reconciliation Form. For further information, please contact Customer Service at 800-716-6700.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 212
- Distribution
- Worldwide Distribution including states of AL,AZ, CA, CO, CT, FL, IL, IN, IA, KS, KY, LA,ME, MA, MI, MN, MO, MT, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, WV, WI, and VA. Counties of SWEDEN, TUNISIA, SW
- Date initiated
- 2008-07-01
- Date posted
- 2008-09-26
- Date terminated
- 2011-12-10
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMUS GPS BILIARY STENT SYSTEM (K061566) | Ev3, Inc. | 2006-08-31 |