Visi-Pro PXB35-05-27-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684036228), received between Jun 2, 2020 and Jun 2, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• MalfunctionJun 2, 2020Burst Container or Vessel; Positioning Problem; Burst Container or Vessel; Positioning Problem

  PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO BALLOON EXPANDABLE STENT DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL COMMON ILIAC ARTERY WITH 75% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 20MM RESPECTIVELY. THE VESSEL WAS MODERATELY TORTUOUS. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE BALLOON RUPTURED CIRCUMFERENTIALLY DURING STENT DEPLOYMENT. INFLATION DEVICE WAS USED TO INFLATE BALLOON. THE BALLOON RUPTURED AT 8ATM. THE LESION WAS PRE DILATED USING A 8X60X80 EVERCROSS PTA BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE WHEN ADVANCING THE DEVICE. THE BALLOON DID NOT FRAGMENT. A NON-MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE VISIPRO STENT WAS IMPLANTED AT THE TARGET LESION AND POST DILATED WITH A NON-MEDTRONIC COVERED STENT. THERE WAS NO VESSEL DAMAGE RELATED TO THE BALLOON RUPTURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10110978 ↗

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