Visi-Pro PXB35-08-37-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684036501), received between Jul 7, 2017 and Mar 20, 2018 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• DeathMar 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO A PROCEDURE TO STENT BILATERAL COMMON ILIAC ARTERIES, PICTURES TAKEN SHOWED STENOSIS ON THE LEFT COMMON FEMORAL AND THE BILATERAL ILIAC ARTERIES. A 6X40X135 EVERCROSS BALLOON WAS USED FOR BILATERAL ILIAC PRE-DILATION. ACCESS FOR THE PROCEDURE WAS ACHIEVED THOUGH THE RIGHT COMMON FEMORAL ARTERY. IT WAS REPORTED THAT A 8X57X80 VISIPRO WAS PLACED IN THE RIGHT COMMON ILIAC WHILE A 8X37X80 VIS-PRO WAS PLACED IN THE LEFT COMMON ILIAC. BOTH STENTS WERE REPORTED TO HAVE BEEN DEPLOYED AT THE SAME TIME. IT WAS REPORTED THAT THE LEFT SIDE WAS DONE FIRST FOLLOWED BY THE RIGHT SIDE. POST DEPLOYMENT IMAGES SHOWED NO EVIDENCE OF LEAKS OR BLEEDING. POST-PROCEDURE IT WAS REPORTED THAT THE PATIENT DEVELOPED COMPLICATIONS AND DIED.

  Patient problems: Death

  MAUDE report 7354863 ↗
• InjuryJul 7, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE A VISI-PRO BALLOON EXPANDABLE STENT WITH A 6FR CORDIS 15 CM SHEATH AND CORDIS AQUATRACK GUIDEWIRE FOR THE TREATMENT OF A 60 MM MODERATELY CALCIFIED, SEVERELY TORTUOUS FIBROUS LESION IN MID/ DISTAL LOCATION IN THE LEFT COMMON ILIAC ARTERY OF DIAMETER 8 MM. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%). EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT WAS REPORTED THAT DURING REMOVAL, FOLLOWING FAILED DELIVERY OF THE DEVICE, STENT DISLODGEMENT OCCURRED. THE DISLODGED STENT WAS NOT REMOVED. AN ADDITIONAL STENT (PROTÉGÉ 7 MM X 40 MM) WAS USED TO PUSH AGAINST THE ARTERIAL WALL. LESION WAS PRE-DILATED USING A 5 MM PRE-DILATION DEVICE. THE PROTÉGÉ 7 MM X 40 MM DEVICE WAS PASSED THROUGH THE DISLODGED VISI-PRO STENT TO SCAFFOLD AND SECURE THE STENT AGAINST THE ARTERIAL WALL WITH RESISTANCE ENCOUNTERED REQUIRING EXCESSIVE FORCE FOR DELIVERY. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6692872 ↗

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