Visi-Pro™ PXB35-08-37-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169787872), received between Apr 1, 2020 and Aug 14, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A VISI PRO STENT AND A PROTÉGÉ EVERFLEX STENT WERE USED TO TREAT THE LEFT COMMON ILIAC, EXTERNAL ILIAC. APPROXIMATELY 11 MONTHS POST PROCEDURE PATIENT SUFFERED RESTENOSIS WITHIN THE DISTAL EXTERNAL ILIAC/COMMON FEMORAL VESSELS. FROM LAST FOLLOW UP, PATIENT COMPLAINED OF BILATERAL HIP PAIN AND ANKLE BRACHIAL INDEX DROPPED BILATERALLY. WENT TO OPERATION ROOM FOR LEFT FEMORAL POPLITEAL BYPASS, BALLOON ANGIOPLASTY OF LEFT EXTERNAL ILIAC ARTERY (TARGET LESION) STENTS DUE TO RESTENOSIS. PATIENT RECOVERED.

  Patient problems: Pain; Stenosis

  MAUDE report 22804632 ↗
• InjuryNov 16, 2022Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT 2 VISIPRO BALLOON EXPANDABLE STENTS WERE INTENDED TO BE IMPLANTED FOR THE TREATMENT OF A CALCIFIED LESION IN THE PROXIMAL REGION OF THE COMMON ILIAC ARTERY. THE ARTERY HAD SEVERE CALCIFICATION. A6 FR NON-MDT SHEATH WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE STENT DEFORMATION OCCURRED DURING POSITIONING/DEPLOYMENT AND THE STENT DISLODGED DURING REMOVAL OF THE STENT. THE PHYSICIAN USED A SNARE TO REMOVE THE DISLODGED STENT AFTER ADVANCING THE STENT THROUGH THE LESION WITHOUT PRE DILATING AND WITHOUT A SHEATH TO COVER THE LESION. THE DISLODGED STENT WAS SUCCESSFULLY REMOVED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS USED. A SECOND STENT WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED AFTER THE STENT WAS DEPLOYED THE PHYSICIAN WENT TO RE INFLATE THE BALLOON IN ANOTHER PART OF THE STENT AND THE BALLOON BURST, THEN WHEN TRYING TO REMOVE IT THE BALLOON BROKE AT THE DISTAL END. IT IS NOT KNOWN AT WHAT ATM THE BALLOON BURST. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: Insufficient Information

  MAUDE report 15804616 ↗
• InjuryMay 20, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID COMMON ILIAC ARTERY. SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. PRE-DILATION WAS PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED DURING ADVANCEMENT, BUT NO EXCESSIVE FORCE WAS USED. IT IS REPORTED STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE STENT WAS REMOVED USING A SNARE. A SECOND STENT WAS OPENED AND ADVANCED. WHEN THE STENT WAS IN THE TARGET LOCATION IT IS REPORTED THE C-ARM MALFUNCTIONED AND THE STENT WAS PULLED OUT AND NOT DEPLOYED. PATIENT IS ALIVE WITH NO INJURY AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11854260 ↗
• MalfunctionJun 12, 2020Material Deformation; Material Deformation

  PATIENT CALLER REPORTED LEFT LEG STENT "COLLAPSING". THE PATIENT REPORTED HAVING TWO STENTS IMPLANTED, ONE IN THE RIGHT LEG AND ONE IN THE LEFT LEG . APPROXIMATELY 4.5 MONTHS POST-PROCEDURE, THE PATIENT¿S PHYSICIAN INFORMED HIM THAT THE STENT IMPLANTED IN THE LEFT LEG HAS COLLAPSED, AND TREATMENT OPTIONS WILL BE LOOKED AT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Obstruction/Occlusion; Reocclusion

  MAUDE report 10147677 ↗
• InjuryApr 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A VISI-PRO BALLOON EXPANDABLE STENT SYSTEM DURING TREATMENT OF THE PATIENT¿S COMMON ILIAC ARTERY. NO DAMAGE NOTED TO PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED DURING REMOVAL OF THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED DURING DELIVERY TO THE LESION THE STENT DISLODGED FROM THE BALLOON. THE DISLODGED STENT WAS REMOVED, AND A NEW STENT WAS IMPLANTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910135 ↗