Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-08
FDA device recall Z-0478-2010 · posted 2009-12-01 · Terminated
Recall details
- Recalling firm
- Ev3, Inc.
- Reason for recall
- ev3 has determined that a lot of 150mm Protg EverFlex Biliary Stent System contains a 100mm length Self-Expanding stent. The implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may require subsequent intervention.
- Action taken
- Two separate letters were sent to United States and international consignees on November 9, 2009. The letter to US consignees was addressed to Cath Lab Managers while the letter to foreign consignees was addressed to the Risk Manager or Cath Lab Manager. The letters described the affected product, gave an Issue Summary and Required Action, which advised consignees to locate and remove the recalled product. An Ev3, Inc. sales representative will contact consignees to arrange return of all unused product to Ev3, Inc. Direct questions regarding the recall to Ev3, Inc. by calling Customer Service at 1-800-716-6700.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 6 (United States) and 6 (Outside United States)
- Distribution
- Worldwide Distribution -- United States (TX and FL), GERMANY, FRANCE and UNITED KINGDOM.
- Date initiated
- 2009-11-06
- Date posted
- 2009-12-01
- Date terminated
- 2012-03-08
- 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 |
|---|---|---|
| PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM (K060057) | Ev3, Inc. | 2006-03-08 |