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ev3 Protg EverFlex Self-Expanding Biliary Stent System… recallZ-1598-2010 · Ev3, Inc. · initiated Mar 31, 2010

Terminated All recalls posted in May 2010

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 is conducting a voluntary recall on three lots of the Protg EverFlex" Biliary Stent System. They determined that a lot of 120mm Protg EverFlex" Biliary Stent system may contain a 150mm length Self-Expanding stent and two lots o 150mm Protg EverFlex" Biliary Stent System may contain a 120 mm length Self-Expanding stent.

FDA root cause category: Mixed-up of materials/components

What the company is doing

ev3 issued "Medical Device Recall" notifications dated March 31, 2010 addressed to "Dear Risk Manager or Cath Lab Manager". Each letter addressed the affected product. Users were instructed to locate and remove from use the affected product and a sales representative will be in contact shortly to arrange for return. For further information, contact ev3 Customer Service at 1-800-716-6700.

Recall details

Recall number
Z-1598-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 31, 2010
Posted by the FDA
May 13, 2010
Recalling firm
Ev3, Inc.
Quantity
19
Product code
FGE
FDA submissions
K060057
Distribution
Nationwide Distribution -- CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA.

Product description

ev3 Protg EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929. Intended as a palliative treatment of malignant neoplasms in the biliary tree.

Code information (models, lots, serial numbers)

Lot Numbers: 7857377, 7856788 and 7858698.

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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