Visi-Pro PXB35-08-27-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684036495), received between Dec 6, 2017 and Nov 30, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2018Use of Device Problem; Use of Device Problem

  THE PHYSICIAN USED THE VISI-PRO FOR A SUBCLAVIAN PROCEDURE. THE STENT DEPLOYED SUCCESSFULLY AND THERE WERE NO COMPLICATIONS WITH THE PRODUCT OR PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED BUT THAT THE EXPIRATION DATE WAS NOT CHECKED PRIOR TO USE. NO ISSUES WITH LABELING ON PRODUCT WERE IDENTIFIED. THE STENT REMAINS IN THE PATIENT, NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8119376 ↗
• InjuryJul 30, 2018Malposition of Device; Device Dislodged or Dislocated; Malposition of Device

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO BALLOON EXPANDABLE STENT TO TREAT A LESION IN THE SUBCLAVIAN ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED AND NO EMBOLIC PROTECTION WAS USED. THERE WAS NO RESISTANCE ENCOUNTERED ADVANCING THE DEVICE AND IT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON EXPANDABLE STENT DISLODGED UPON ATTEMPTS TO DEPLOY IT IN THE SUBCLAVIAN. IT WAS RETRIEVED BUT WAS NOT ABLE TO BE WITHDRAWN THROUGH THE SHEATH SO THEY DEPLOYED THE STENT IN THE COMMON ILIAC. ANOTHER STENT WAS USED TO TREAT THE SUBCLAVIAN.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 7731489 ↗
• MalfunctionMar 9, 2018Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO FOR THE TREATMENT OF A SLIGHTLY CALCIFIED CTO LESION IN THE RIGHT COMMON ILIAC ARTERY. THE IFU WAS FOLLOWED AND THE DEVICE PREPPED WITHOUT ISSUE. IT IS REPORTED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN THEN FURTHER DILATED THE LESION WITH UNKNOWN MAKE OF CORONARY BALLOONS OF THE FOLLOWING SIZES: 1.5X15MM, 2.5X15MM & 3X20MM. THE PHYSICIAN COMPLETED PROCEDURE USING ANOTHER MEDTRONIC DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7326471 ↗
• MalfunctionDec 6, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE A VISI-PRO BALLOON-EXPANDABLE STENT TO TREAT A 20 CM SEVERELY CALCIFIED LESION IN THE LEFT PROXIMAL COMMON ILIAC ARTERY. THE VESSEL HAD LITTLE TORTUOSITY AND THE LESION HAD 90% STENOSIS. THE ARTERY DIAMETER WAS 7.67MM. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A 0.035" NON-MEDTRONIC GUIDEWIRE. THE VISI-PRO WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS PRE-DILATED USING AN 4X4X40 EVERCROSS PTA BALLOON WITHOUT DIFFICULTY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. DURING THE FIRST INFLATION AT 8 ATMS, THE STENT BALLOON BURST LONGITUDINALLY. THE VESSEL WAS SUCCESSFULLY STENTED USING THE VISI-PRO BALLOON-EXPANDABLE STENT, DESPITE RUPTURE OF THE STENT BALLOON. THE FRACTURED BALLOON WAS REMOVED, AND NO INTERVENTION WAS REQUIRED TO REMOVE ANY BALLOON PARTICULATES. THE LESION WAS THEN POST-DILATED WITH THE 8X40 EVERCROSS PTA BALLOON. THERE WAS RUPTURE WITH THIS BALLOON AS WELL DURING INFLATION. THE BALLOON WAS REMOVED, AND NO INTERVENTION WAS REQUIRED TO REMOVE BALLOON FRAGMENTS. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085875 ↗

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