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Protg EverFlex" Self-Expanding Biliary Stent System (for… recallZ-0478-2010 · Ev3, Inc. · initiated Nov 6, 2009

Terminated All recalls posted in December 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ev3, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-0478-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 6, 2009
Posted by the FDA
Dec 1, 2009
Recalling firm
Ev3, Inc.
Quantity
6 (United States) and 6 (Outside United States)
Product code
FGE
FDA submissions
K060057
Distribution
Worldwide Distribution -- United States (TX and FL), GERMANY, FRANCE and UNITED KINGDOM.

Product description

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.

Code information (models, lots, serial numbers)

United States lot # 7821740 and  Outside United States lot # 7821736

Other devices under the same FDA submission

14 devices cleared under K060057 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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