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

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169787865), received between Dec 27, 2019 and May 30, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE STENT PXB35-08-27-135 VISI PRO 035, THE STENT DISLODGED OFF THE BALLOON IN THE PATIENT. A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE WERE USED. THE VESSEL WAS NOT PRE- OR POST-DILATED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS INTENDED TO TREAT A MODERATELY CALCIFIED LESION AND VERY TORTUOUS ANATOMY IN THE LEFT PROXIMAL SUPERIOR MESENTERIC ARTERY, WITH LESION STENOSIS GREATER THAN 70% AND A LESION LENGTH OF 20 MILLIMETERS. THE STENT WAS REMOVED FROM THE PATIENT BY SNARING, AND A CHANGE OF SHEATH WAS PERFORMED. THE PROCEDURE WAS COMPLETED USING A NEW PXB35-07-27-135 VISIPRO STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112959 ↗
• MalfunctionJun 7, 2024Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  A VISIPRO BALLOON EXPANDABLE STENT WAS BEING USED TO TREAT A CALCIFIED LESION WITH 80% LESION STENOSIS IN THE DISTAL LEFT MID SFA. NO ABNORMALITIES IN RELATION TO ANATOMY. LESION WAS PRE-DILATED. NO DAMAGE TO PACKAGING. NO ISSUES WHEN REMOVING PRODUCT FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. IT IS REPORTED THE STENT WOULD NOT DEPLOY, THERE WERE NO DIFFICULTIES INFLATING THE BALLOON AND NO LEAK REPORTED. A DIFFERENT STENT OF SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS ASSOCIATED WITH EVENT. PATIENT IS ALIVE WITH /NO INJURY. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE STENT WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489168 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT REPRESENTATIVE THAT A PATIENT HAS HAD A RASH EVER SINCE HAVING 2 VISI-PRO BALLOON EXPANDABLE STENTS AND 2 PROTÉGÉ EVERFLEX STENTS IMPLANTED TO TREAT THE LEFT ILIAC AND LEFT SFA AND POPITEAL VESSELS. SYMPTOMS STARTED 1 DAY POST PROCEDURE. THE PHYSICIAN DOESN¿T THINK THERE WAS ANY ISSUES DURING STENT IMPLANTATION. PHYSICIAN DID NOT DETERMINE THE STENTS LED TO PATIENT SYMPTOMS. PATIENT CURRENTLY BEING TREATED WITH CREAM PROVIDED BY DERMATOLOGIST. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Rash

  MAUDE report 14208898 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT REPRESENTATIVE THAT A PATIENT HAS HAD A RASH EVER SINCE HAVING 2 VISI-PRO BALLOON EXPANDABLE STENTS AND 2 PROTÉGÉ EVERFLEX STENTS IMPLANTED TO TREAT THE LEFT ILIAC AND LEFT SFA AND POPITEAL VESSELS. SYMPTOMS STARTED 1 DAY POST PROCEDURE. THE PHYSICIAN DOESN¿T THINK THERE WAS ANY ISSUES DURING STENT IMPLANTATION. PHYSICIAN DID NOT DETERMINE THE STENTS LED TO PATIENT SYMPTOMS. PATIENT CURRENTLY BEING TREATED WITH CREAM PROVIDED BY DERMATOLOGIST. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Rash

  MAUDE report 14208889 ↗
• MalfunctionAug 19, 2021Inflation Problem; Device Dislodged or Dislocated; Inflation Problem; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE A VISIPRO BALLOON EXPANDABLE STENT ALONG WITH 6FR SHEATH DURING PROCEDURE TO TREAT A NONE CALCIFIED PLAQUE LESION IN THE LEFT DISTAL SUBCLAVIAN ARTERY. THE VESSEL WAS MODERATELY TORTUOUS. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE STENT DEPLOYED IN UNINTENDED LESION SITE (INACCURATE DELIVERY). THE LESION SITE HAD SUFFICIENT LANDING ZONE. THE BALLOON INFLATED UNEVENLY AND CAUSED WATERMELON SEEDING OF STENT. THIS CAUSED STENT TO SLIDE OFF THE SHAFT AND BE DEPLOYED DISTAL TO LANDING ZONE. AN EVERCROSS PTA (7X30) BALLOON WAS USED TO PRE DILATE THE LESION. THERE WAS NO RESISTANCE WHEN ADVANCING THE DEVICE. STENT WAS DEPLOYED BUT NOT IN THE CORRECT LANDING ZONE. ABNORMAL DEPLOYMENT LEFT STENT HANGING INTO AORTA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340832 ↗
• InjuryFeb 27, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  PHYSICIAN USED A VISIPRO BALLOON EXPANDABLE STENT SYSTEM DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S COMMON ILIAC ARTERY. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED GREATER THAN 90% STENOSIS. IFU WAS FOLLOWED. NO ISSUES NOTED TO DEVICE PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. DEVICE PREPPED WITHOUT ISSUE. IT IS REPORTED DURING DELIVERY TO THE LESION, THE STENT DISLODGED IN THE AORTA. A SNARE WAS ATTEMPTED TO BE USED TO REMOVE THE STENT UNSUCCESSFULLY, RESULTING IN THE STENT BEING PUSHED INTO THE RIGHT RENAL ARTERY. THE STENT COULD NOT BE REMOVED FROM THE PATIENT¿S RIGHT RENAL ARTERY. PHYSICIAN DECIDED TO LEAVE THE STENT IN THE PATIENT¿S RIGHT RENAL ARTERY. NO FURTHER INTERVENTION PERFORMED TO TRY AND REMOVE THE STENT. A SECOND VISIPRO DEVICE WAS OPENED TO TREAT THE INTENDED LESION IN THE PATIENT¿S COMMON ILIAC ARTERY. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763664 ↗
• 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 9523207 ↗