Visi-Pro PXB35-08-37-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684036518), received between Dec 14, 2017 and Aug 19, 2019 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2019Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A VISI PRO BALLOON EXPANDABLE STENT SYSTEM WITH A 6FR SHEATH DURING TREATMENT OF A 30MM CALCIFIED LESION IN THE PATIENT¿S MID COMMON ILIAC ARTERY OF DIAMETER 8MM. MODERATE TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 80% STENOSIS. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE STENT SYSTEM. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE SHEATH WAS UPSIZED, AND A SNARE WAS USED TO REMOVE THE DISLODGED STENT. PATIENT TO BE SCHEDULED FOR AN ENDARTERECTOMY AND ILIAC STENT WILL BE PLACED AT THAT TIME.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8905296 ↗
• MalfunctionSep 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A VISI PRO BALLOON EXPANDABLE STENT FOR TREATMENT OF A LESION IN THE PATIENT¿S COMMON ILIAC ARTERY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY. THE DISLODGED STENT WAS REMOVED BUT IT WAS NOT REPORTED HOW IT WAS REMOVED. ANOTHER STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7841373 ↗
• MalfunctionFeb 6, 2018Difficult to Remove; Difficult to Remove

  THE PHYSICIAN WAS USING A VISI-PRO BALLOON-EXPANDABLE STENT TO TREAT A LESION IN THE COMMON ILIAC ARTERY. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE STENT WAS DEPLOYED CORRECTLY WITHOUT ANY ISSUE, BUT THE BALLOON GOT STUCK IN THE SHEATH AFTER THE STENT WAS DEPLOYED. THE PROCEDURE WAS FINISHED WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7246773 ↗
• InjuryDec 14, 2017Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A VISI-PRO BALLOON EXPANDABLE STENT TO TREAT A 30 MM SEVERELY CALCIFIED LESION IN THE LEFT PROXIMAL SUBCLAVIAN ARTERY. THE ARTERY WAS MODERATELY TORTUOUS AND HAD A DIAMETER OF 7-8 MM. THE LESION HAD RESULTED IN 90-95% STENOSIS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 0.035" NON-MEDTRONIC GUIDEWIRE AND A 7 FR NON-MEDTRONIC SHEATH. NO EMBOLIC PROTECTION WAS USED. THE LESION WAS NOT PRE-DILATED. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. DURING THE FIRST INFLATION OF THE DEVICE, THE STENT WAS DEPLOYED BUT THE BALLOON BURST AT 11 ATMS. THE TIP OF THE BALLOON CATHETER BROKE OFF REMAINING IN THE PATIENT ON THE WIRE. ATTEMPTS WERE MADE TO SNARE THE DEVICE WITH NO SUCCESS. TWO GOOSENECK SNARES AND ONE NON-MEDTRONIC SNARE WERE UNSUCCESSFULLY TRIED TO SNARE THE TIP OF BALLOON. THE BALLOON TIP WAS PULLED DOWN TO THE BIFURCATION. TWO KISSING NON-MEDTRONIC STENTS WERE DEPLOYED ENTRAPPING THE BALLOON TIP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7120227 ↗

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