Visi-Pro PXB35-07-57-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684036440), received between Sep 6, 2017 and Sep 6, 2017 — 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.

• InjurySep 6, 2017Difficult or Delayed Positioning; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Device Dislodged or Dislocated

  THE PHYSICIAN WAS ATTEMPTING TO USE A VISI-PRO BALLOON EXPANDABLE STENT TO TREAT A LESION WITH A SEVERE DEGREE OF TORTUOSITY AND CALCIFICATION AND DEMONSTRATING (B)(4) STENOSIS AT THE COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS PREPPED PER THE IFU. NO EMBOLIC PROTECTION WAS USED DURING THE PROCEDURE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE USED DURING DELIVERY AND WITHDRAWAL. IT WAS REPORTED THAT DEPLOYMENT ISSUES WERE EXPERIENCED AND THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT RESULTING IN A DELIVERY FAILURE. THE STENT DISLODGED DURING REMOVAL, WHICH REQUIRED INTERVENTION. THIS DISLODGED STENT WAS NOT REMOVED AND IT REMAINED IN PLACE. IT WAS REPORTED THAT A BALLOON WAS PASSED THROUGH THE DISLODGED STENT AND IT WAS DEPLOYED. THE PHYSICIAN USED ANOTHER STENT TO COMPLETE THE PROCEDURE. PATIENT INJURY WAS REPORTED AND COMPLICATIONS FOLLOWING THE INCIDENT INCLUDED VESSEL DAMAGE/INJURY, PERFORATION, HEMATOMA AND HEMORRHAGE/BLEED AT THE ACCESS SITE. PATIENT EXPERIENCED RETROPERITONEAL BLEEDING. A COMMON FEMORAL CUT-DOWN PROCEDURE WAS PERFORMED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem; Perforation

  MAUDE report 6844191 ↗

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