Visi-Pro™ PXB35-06-12-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169787650), received between Jan 30, 2020 and Apr 3, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE RIGHT SUBCLAVIAN ARTERY, A LABELING/PACKAGING ISSUE OCCURRED WITH THE STENT PX B35-06-12-080 VISI PRO 035. THE NURSE OPENED A BOX LABELED FOR A 6X17 STENT, BUT ONCE THE STENT WAS IN THE PATIENT, IT WAS REALIZED THAT THE STENT WAS 6X12. THE STERILE PACKAGING WAS INTACT. THE 6X17 BOX HAD BEEN PREVIOUSLY OPENED. DESPITE THE DISCREPANCY, THE PHYSICIAN DECIDED TO PLACE THE 6X12 STENT AS IT WAS DEEMED ADEQUATE, ALTHOUGH A 6X17 WAS PREFERRED. THE LESION WAS FIBROUS WITH MINIMAL TORTUOSITY AND CALCIFICATION, 75%+ STENOSIS, 10MM IN LENGTH, AND THE ARTERY DIAMETER WAS 6MM. A 6FR NON-MEDTRONIC SHEATH AND A 035 NON-MEDTRONIC GUIDEWIRE WERE USED. THE VESSEL WAS POST-DILATED USING THE BALLOON ON THE VISIPRO BEING REPORTED. THE PROCEDURE WAS COMPLETED WITH THE SHORTER STENT AS THE PHYSICIAN FELT IT WAS SUFFICIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760968 ↗
• MalfunctionJul 28, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  PHYSICIAN INTENDED TO USE AN VISI PRO BALLOON EXPANDABLE STENT SYSTEM WITH A NON-MEDTRONIC 6FR SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL CELIAC VESSEL. SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. VESSEL DIAMETER AND LESION LENGTH REPORTED AS 6MM AND 10MM RESPECTIVELY. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING A 5MM NON-MEDTRONIC (MUSTANG BSC) PTA BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING DEPLOYMENT. IT IS REPORTED 12MM OF THE STENT HAD NOT DEPLOYED. DISLODGEMENT OF THE STENT IS REPORTED BUT IT REMAINED ON THE BALLOON AND WAS PULLED OUT BY THE PHYSICIAN WITH RESISTANCE. IT IS BELIEVED A STENT STRUT MAY HAVE BECOME CAUGHT ON CALCIUM IN THE VESSEL. THE PHYSICIAN THEN USED A SECOND VISI PRO OF THE SAME SIZE TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO VESSEL DAMAGE WAS NOTED. NO PATIENT INJURY R

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331654 ↗
• InjuryJan 30, 2020Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  PHYSICIAN WAS ATTEMPTING TO USE VISI PRO BALLOON EXPANDABLE STENT ALONG WITH 6FR SHEATH AND NON MEDTRONIC .035" GUIDE WIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE LEFT MID BRANCH OF INTERNAL ARTERY WITH 95% STENOSIS. THE VESSEL IS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 8MM RESPECTIVELY. THE DEVICE WAS PREPPED PER IFU WITH ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING ADVANCEMENT, THE DEVICE COULD NOT CROSS BECAUSE OF STENOSIS. DURING ATTEMPT TO REMOVE DEVICE TO PRE DILATE THE LESION, THE STENT CAME OFF THE BALLOON WHEN IN THE BRANCH OF INTERNAL ILIAC ARTERY. THE DISLODGED STENT COULD NOT BE SNARED DUE TO THE SMALL BRANCH IN WHICH IT DISLODGED IN THE INTERNAL ILIAC ARTERY. THE PROCEDURE WAS COMPLETED USING ANOTHER VISI PRO STENT. THERE WAS NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 9646895 ↗