Visi-Pro™ PXB35-07-57-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169787827), received between Mar 5, 2019 and Feb 13, 2025 — classified as 2 injuries, 2 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.

• InjuryFeb 13, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE DELIVERY OF A VISI PRO BALLOON EXPANDABLE STENT TO THE LESION IN THE PROXIMAL LEFT ILIAC ARTERY, STENT DISLODGEMENT OCCURRED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE LESION WAS CHARACTERIZED BY PLAQUE WITH A 90-100% STENOSIS, LITTLE TORTUOSITY, AND MODERATE CALCIFICATION. THE DISLODGED STENT WAS INFLATED AND KEPT BELOW THE STENOTIC AREA, AND ANOTHER VISI PRO 7X37 STENT WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21374300 ↗
• MalfunctionNov 22, 2024Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S RIGHT PROXIMAL COMMON ILIAC ARTERY. LESION EXHIBITED 70% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 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. THE DEVICE WAS PREPPED PER THE IFU (INSTRUCTION FOR USE) WITH NO ISSUES IDENTIFIED. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE VISIPRO STENT WAS SUPPOSED TO BE DEPLOYED AT THE RIGHT COMMON ILIAC ARTERY BUT SUDDENLY DISLODGED FROM THE CATHETER AT THE BRACHIAL ARTERY DURING THE ADVANCEMENT OF THE CATHETER. THE DISLODGED STENT WAS NOT REMOVED. IT WAS DEPLOYED AND EXPANDED BY A BALLOON CATHETER. A REPLACEMENT 8MM VISIPRO STENT WAS USED TO TREAT THE TARGET LESION IN THE RIGHT COMMON ILIAC ARTERY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755805 ↗
• MalfunctionJul 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A VISI PRO BALLOON EXPANDABLE STENT SYSTEM WITH A NON-MEDTRONIC 6FR SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 50MM CALCIFIED LESION IN THE PATIENT¿S LEFT COMMON ILIAC ARTERY. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. VESSEL DIAMETER REPORTED AS 7MM. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING AN EVERCROSS PTA BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING POSITIONING AND IT WAS OBSERVED THE EDGE OF THE STENT PROXIMALLY WAS FLARED UP. IT IS REPORTED THAT 57MM OF THE STENT DEPLOYED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS REMOVED ON ITS OWN BALLOON CATHETER AND REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10250891 ↗
• InjuryMar 5, 2019Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A VISIPRO 035 STENT TO TREAT A LESION IN THE ILIAC. THE LESION WAS NOT PRE-DILATED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 5/6FR NON-MEDTRONIC SHORT SHEATH AND A NON-MEDTRONIC 0.035 GUIDEWIRE WERE USED FOR THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED NOR WAS EXCESSIVE FORCE APPLIED DURING ATTEMPTED DELIVERY OF THE DEVICE TO THE LESION. IT WAS REPORTED THAT THE STENT DEPLOYED IN THE POSTERIOR TIBIAL ARTERY. THE PHYSICIAN FINISHED THE CASE BY STENTING THE ILLAC WITH A 7 X 60 PROTÉGÉ SE STENT. THE PHYSICIAN ALSO TREATED THE SFA USING A HAWKONE, FOLLOWED BY 2, 6 X 150 PROTÉGÉ STENTS FOLLOWED BY POST DILATION USING A 6 X 100 DEVICE. IT WAS REPORTED THAT THE PATIENT¿S POSTERIOR TIBIAL WAS OCCLUDED.

  Patient problems: Occlusion; Patient Problem/Medical Problem

  MAUDE report 8390381 ↗