Visi-Pro PXB35-07-57-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684036457), received between Sep 23, 2019 and Sep 23, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 18, 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 23, 2019Fracture; Fracture

  A VISI PRO STENT WAS USED DURING TREATMENT OF A 30MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL LEFT COMMON ILIAC ARTERY OF DIAMETER 7MM. MODERATE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 40% STENOSIS. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING A 6 MM PRE-DILATION DEVICE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT, BUT NO RESISTANCE WAS ENCOUNTERED. PATIENT WAS SCHEDULED FOR RE-INTERVENTION DUE TO REST PAIN WHERE IT WAS DISCOVERED THAT THE PREVIOUSLY DEPLOYED STENT HAD A COMPLETE FRACTURE. APPROXIMATELY 30 MM OF THE STENT SEPARATED AND DRIFTED INTO THE DISTAL AORTA. THE REMAINDER OF THE STENT REMAINED IN THE LEFT COMMON ARTERY. IT HAS NOT BEEN CONFIRMED IF THE FRACTURE OCCURRED AT TIME OF PROCEDURE OR WAS ALREADY SEPARATED PRIOR TO ANGIOGRAM. THERE WERE REPEAT INTERVENTIONS COMPLETED AFTER AND IT APPEARED THAT THE STENT MIGHT HAVE BEEN COMPROMISED BEFOREHAND BUT UNCERTAIN. THE SEPARATED STENT WAS NOTICED ON ANGIOGRAM APPROXIMATELY 1 YEAR POST PROCEDURE. IT WAS REPORTED THE PHYSICIAN TRIED TO REWIRE STENT IN DISTAL AORTA AND GET BALLOON INSIDE STENT TO PULL BACK IN LEFT COMMON ILIAC. THIS WAS U

  Patient problems: Injury; Pain

  MAUDE report 9103708 ↗

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