Visi-Pro PXB35-08-17-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684036471), received between Jun 23, 2017 and Sep 1, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2017Device Slipped; Activation, Positioning or Separation Problem; Device Slipped; Activation, Positioning or Separation Problem

  PHYSICIAN INTENDED TO USE A VISI-PRO BALLOON-EXPANDABLE STENT WITH 6 FR NON-MEDTRONIC SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE FOR THE TREATMENT OF A 10MM MODERATELY TORTUOUS, CALCIFIED PLAQUE LESION IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY OF DIAMETER 8MM. LESION EXHIBITED (B)(4) STENOSIS. EMBOLIC PROTECTION WAS NOT USED. IFU WAS FOLLOWED AND DEVICE WAS PREPPED WITHOUT ISSUE. LESION WAS NOT PRE-DILATED. DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING ITS DELIVERY TO THE LESION. THE PHYSICIAN WAS SUCCESSFUL IN RECAPTURING THE STENT OVER THE ORIGINAL BALLOON BY INFLATING AND COULD ADVANCE TO THE LESION SITE. THE STENT WAS THEN SUCCESSFULLY DEPLOYED AT CORRECT SITE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6837229 ↗
• InjuryJun 23, 2017Migration or Expulsion of Device; Activation, Positioning or Separation Problem; Migration or Expulsion of Device; Activation, Positioning or Separation Problem

  PHYSICIAN EMPLOYED THE USE OF A VISI PRO STENT WITH A 6FR SHEATH AND .035 GUIDEWIRE FOR TREATMENT OF A 13MM MODERATELY CALCIFIED, MODERATELY TORTUOUS PLAQUE LESION IN PROXIMAL LOCATION IN THE LEFT COMMON ILIAC ARTERY OF DIAMETER 6MM WHICH EXHIBITED >60% STENOSIS. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. WHEN ADVANCING THE DEVICE, THE PHYSICIAN ENCOUNTERED RESISTANCE. IT WAS REPORTED THAT DURING DELIVERY OF THE STENT, IT CAME OFF IN THE SHEATH (FROM THE LEFT CONTRALATERAL) WHILE ATTEMPTING TO STENT THE RIGHT COMMON ILIAC. THE SHEATH WAS PULLED BACK AND THE BALLOON WAS ABLE TO RETRIEVE THE STENT BUT IT HAD MIGRATED OUT OF THE SHEATH. THE STENT WAS DEPLOYED IN THE LEFT COMMON ILIAC AND ON DEPLOYMENT, VESSEL DISSECTION OCCURRED. AN EVERFLEX 6X60 STENT WAS DEPLOYED TO COVER THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 6665575 ↗

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