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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169787841), received between Dec 27, 2019 and Jan 9, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

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.

• MalfunctionJan 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE TO EXTEND THE LOWER LIMB OF A GRAFT IN A PATIENT, A STENT WAS INTRODUCED INTO THE SHEATH AND ADVANCED INTO THE LEFT DISTAL COMMON ILIAC ARTERY, WHICH WAS NOTED TO BE HEAVILY CALCIFIED. SEVERE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT DUE TO THE CALCIFIED VESSEL. UPON ATTEMPTING TO REMOVE THE STENT SYSTEM, THE STENT WAS FOUND TO HAVE DETACHED FROM THE BALLOON AND REMAINED IN THE SHEATH, RESULTING IN STENT DISLODGEMENT AND THE STENT NOT BEING DEPLOYED IN THE PATIENT. THE DEVICE WAS SAFELY REMOVED, AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24018430 ↗
• MalfunctionMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LIMITED INFORMATION REPORTED THAT DURING USE OF A VISIPRO BALLOON EXPANDABLE STENT THE STENT DISLODGED DURING USE IN THE PATIENT AND WAS TRAPPED IN THE AORTA AND LEFT BEHIND THE GRAFT. STENT WAS LOST IN PATIENT AND WAS NOT REMOVED. THERE WAS A DELAY IN THE PROCEDURE BUT DID NOT RESULT IN ANY HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281411 ↗
• MalfunctionFeb 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE THE VISI-PRO BALLOON EXPANDABLE STENT DURING PROCEDURE TO TREAT SEVERELY CALCIFIED PLAQUE IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD LITTLE TORTUOSITY AND EXHIBITED 80% STENOSIS. A NON-MEDTRONIC 5FR SHEATH AND 0.035X 260CM GUIDEWIRE WERE USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE LESION WAS PRE-DILATED WITH A 6MMX40MM BALLOON. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT WAS DISLODGED BEFORE IT WAS ABLE TO BE DELIVERED. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT WITH THE STENT PARTIALLY ATTACHED TO THE DEVICE. NO PART OF THE STENT OR DEVICE WAS LEFT IN THE PATIENT. ANOTHER STENT OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13547784 ↗
• InjuryDec 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS USING VISI PRO BALLOON EXPANDABLE STENTS ALONG WITH NON MEDTRONIC 6FR SHEATH AND GUIDE WIRE DURING PROCEDURE TO TREAT LITTLE CALCIFIED PLAQUE LESION IN THE LEFT PROXIMAL COMMON ILIAC WITH 60% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH IN THE LEFT LEG WAS 8MM AND 30MM RESPECTIVELY AND 8MM AND 15MM ON THE RIGHT LEG RESPECTIVELY. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT DURING DELIVERY OF DEVICE TO LESION IN THE LEFT LIMB, THE STENT DISLODGED. AS THE STENT WAS BEING RE-POSITIONED TO DEPLOY, THE BALLOON DISLODGED FROM STENT. THE STENT WAS THEN PARTIALLY DEPLOYED AND BALLOON ADVANCED AND REST OF STENT EXPANDED. STENT EXPANDED WITH BALLOON ONLY PARTIALLY IN STENT THEN BALLOON ADVANCED AND REST OF STENT EXPANDED. DURING DELIVERY OF SECOND STENT TO THE RIGHT LIMB IT ALSO DISLODGED. IT WAS REPORTED THAT AN ATTEMPT TO REMOVE ADVANCED DEVICE AS PHYSICIAN DECIDED TO USE A LONGER STENT, THE STENT DISLODGED FROM BALLOON. AN ATTEMPT TO ADVANCE BALLOON BACK THROUGH THE STENT FAILED BUT BALLOON THE PUSHED STENT INTO AORTA. PHYSICIAN USED A SNARE OPPOSITE SIDE TO HELP WITH ABILITY TO PUSH THE BALLOON INTO THE UNEXPANDED STENT WHICH IS IN PROXIMAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9523212 ↗