Z-0478-2010

Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model #...

Name: Z-0478-2010 Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model #...
Creator: Ev3, Inc.
Published: 2009-11-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-11-06 / Terminated / root cause: labeling and UDI

FDA source

Ev3, Inc. began a recall of Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan... on 2009-11-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0478-2010
Status: Terminated
Initiated: 2009-11-06
Posted: 2009-12-01
Terminated: 2012-03-08
Recalling firm: Medtronic, Inc.
Product: Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. Protg EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, superficial femoral, proximal popliteal, or subclavian arteries.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 6 (United States) and 6 (Outside United States)
Distribution: Worldwide Distribution -- United States (TX and FL), GERMANY, FRANCE and UNITED KINGDOM.
Product codes and lots: United States lot # 7821740 and Outside United States lot # 7821736

Product code FGE

K060057Class IIProtege Everflex Self-Expanding Biliary Stent SystemEv3, Inc. / cleared 2006-03-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)