Recall Z-1547-2008
Ev3, Inc · initiated July 1, 2008
Product
ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080, PXB35-08-17-080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135 ,PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and PXB35-10-37-080. The Endovascular Company , 4800 Nathan Lane North, Plymouth, MN
Codes / lots: Lot Numbers: 3273766, 3273767, 3509137, 4218926, 4361370, 4472112, 4941116, 5012047, 5282885, and 5834997.
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.
FDA-determined cause: Employee error
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.
Details
- Recall number
- Z-1547-2008
- Initiated
- July 1, 2008
- Posted by FDA
- September 26, 2008
- Terminated
- December 10, 2011
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Quantity
- 66
- 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, SWITZERLAND, GERMANY, ITALY, SLOVENIA, FRANCE, BELGIUM, UNITED KINGDOM, TURKEY, FINLAND, LITHUANIA, and NORWAY.
- Recalling firm
- Ev3, Inc, Plymouth, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1548-2008 | ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model…ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate… | 07/01/2008Terminated |