Visi-Pro PXB35-06-17-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684036303), received between Feb 2, 2018 and Nov 11, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryNov 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A VISIPRO BALLOON EXPANDABLE STENT DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S PROXIMAL LEFT RENAL ARTERY. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 90% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS REMOVED BY PERFORMING A CUT DOWN ON THE COMMON FEMORAL ARTERY AND USING A (FOGARTY) CATHETER TO PULL THE STENT BACK FROM THE DISTAL SFA OUT OF THE BODY. RENAL ARTERY STENTING WAS NOT COMPLETED.

  Patient problems: Myocardial Infarction; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10822091 ↗
• InjuryFeb 2, 2018Difficult To Position; Device Dislodged or Dislocated; Difficult To Position; Device Dislodged or Dislocated

  THE PHYSICIAN WAS ATTEMPTING TO USE A VISI-PRO BALLOON EXPANDABLE STENT TO TREAT A 15MM SEVERELY CALCIFIED LESION IN THE RIGHT PROXIMAL RENAL ARTERY (90% STENOSIS). THE ARTERY HAD A DIAMETER OF 7 MM AND HAD LITTLE TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 10 FR SHEATH AND A 0.035" GUIDEWIRE. THE VESSEL WAS PRE-DILATED USING A 4X20X80 PREDILATION BALLOON. RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE. THE VISI-PRO STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED. THE STENT WAS SNARED WITH NO REPORTED ISSUES. THE PROCEDURE WAS COMPLETED USING A PARAMOUNT-MINI STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7239278 ↗

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