Visi-Pro PXB35-05-17-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684036204), received between Nov 7, 2018 and Nov 7, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO DEVICE TO TREAT A MODERATELY CALCIFIED LESION WITH 95-99% STENOSIS IN THE RIGHT MID DISTAL ILIAC AND RENAL ARTERIES. ARTERY LENGTH AND LESION DIAMETER WERE 5MM AND 17MM. THE PHYSICIAN USED A 6FR NON-MEDTRONIC 45CM SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO PRE-DILATION WAS PERFORMED PRIOR TO ATTEMPTING TO CROSS THE LESION. THE PHYSICIAN REPORTED EXCESSIVE FORCE WAS USED DURING ADVANCEMENT AND DELIVERY OF THE DEVICE TO ITS DESIRED LOCATION. IT WAS REPORTED THAT THE STENT DISLODGED IN AN UNINTENDED LESION. STENT WAS PARTIALLY SNARED AND WAS DEFORMED DURING SNARE ATTEMPTS. THE STENT THEN BECAME LODGED IN THE RIGHT ILIAC ARTERY. PHYSICIAN WAS UNABLE TO REMOVE THE STENT THROUGH THE SHEATH. THE DISLODGED STENT WAS REMOVED IN THE OR BY OPEN SURGERY. THE PATIENT INCURRED VESSEL OCCLUSION AND A RETROPERITONEAL HAEMORRHAGE DUE TO THE SURGERY TO REMOVE THE STENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Occlusion; Patient Problem/Medical Problem

  MAUDE report 8046319 ↗

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-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
• 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