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ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable… recallZ-1548-2008 · Ev3, Inc · initiated Jul 1, 2008

Terminated All recalls posted in September 2008

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, 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 root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-1548-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 1, 2008
Posted by the FDA
Sep 26, 2008
Recalling firm
Ev3, Inc
Quantity
212
Product code
FGE
FDA submissions
K061566
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.

Product description

ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800. The Endovascular Company, Nathan Lane North, Plymouth, MN 55442-2920,

Code information (models, lots, serial numbers)

Lot Numbers: 4089374, 4140341, 4151887, 4194358, 4239470, 4251836, 4484043, 44804047, 4491290, 4933989, 5005731, 5012045, 5045725, 5117532, 5147416, 5149205, 5214432, 5221941, 5239429, and 5577902.

Other devices under the same FDA submission

28 devices cleared under K061566 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 49366).

Sources and updates

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