Visi-Pro PXB35-08-27-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684036488), received between May 23, 2017 and Apr 2, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K061566); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2019Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  THE PHYSICIAN WAS USING A VISI-PRO TO TREAT A 20-25MM SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY. LITTLE TORTUOSITY WAS REPORTED AND THE VESSEL DIAMETER WAS 8-9MM. A 7FR NON MEDTRONIC SHEATH AND A NON MEDTRONIC 0.035 GUIDEWIRE WAS USED IN THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE LESION WAS PRE-DILATED USING A 7X40X135 DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND THAT THERE WAS DIFFICULTY REMOVING THE DEVICE PRIOR TO STENT DEPLOYMENT. 27MM OF STENT WAS DEPLOYED IN THE VESSEL. THE VISIPRO COULD NOT BE POSITIONED ACCURATELY DUE TO SEVERE CALCIUM. THE STENT WAS THEN REMOVED AND SOME RESISTANCE FELT BY PHYSICIAN BUT THE STENT CAME OUT OF THE SHEATH INTACT. THE PROXIMAL STRUTS WERE INSPECTED BY THE PHYSICIAN AND THEY APPEARED TO BE SLIGHTLY LIFTED FROM THE BALLOON SURFACE. THE PHYSICIAN DECIDED TO USE A DIFFERENT STENT AND CHOSE A 9X27X135 VISIPRO. HE WAS ABLE TO GET THIS STENT POSITIONED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8472737 ↗
• MalfunctionMay 23, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS USING A VISI-PRO BALLOON EXPANDABLE STENT SYSTEM FOR THE TREATMENT IN THE RIGHT MID COMMON ILIAC ARTERY. DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. STENT WAS INSERTED INTO THE SHEATH AND THEN REMOVED OUT OF THE SHEATH. UPON REINSERTION, PHYSICIAN NOTICED THE STENT WAS NOT ON THE BALLOON. STENT WAS OBSERVED IN THE PATIENT, OVER THE WIRE BUT NOT EXPANDED. THE BALLOON WAS PUT BACK IN AND IT WAS ABLE TO GO BACK INSIDE OF THE STENT. ONCE STENT WAS REMOUNTED IT WAS MOVED AND IMPLANTED AT THE CORRECT LOCATION TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6586646 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061566. One submission often covers many models, so check the product and lot details in each record.

• Z-1547-2008 · Jul 1, 2008 · Terminated
  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, PX
• Z-1548-2008 · Jul 1, 2008 · Terminated
  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