Z-1547-2008

ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers...

Name: Z-1547-2008 ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers...
Creator: Ev3, Inc
Published: 2008-07-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-07-01 / Terminated / root cause: manufacturing process

FDA source

Ev3, Inc began a recall of ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080... on 2008-07-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1547-2008
Status: Terminated
Initiated: 2008-07-01
Posted: 2008-09-26
Terminated: 2011-12-10
Recalling firm: Medtronic, Inc.
Product: ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080, PXB35-08-17-080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135 ,PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and PXB35-10-37-080. The Endovascular Company , 4800 Nathan Lane North, Plymouth, MN
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 66
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 codes and lots: Lot Numbers: 3273766, 3273767, 3509137, 4218926, 4361370, 4472112, 4941116, 5012047, 5282885, and 5834997.

Product code FGE

K061566Class IIPrimus Gps Biliary Stent SystemEv3, Inc. / cleared 2006-08-31

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)