Visi-Pro™ PXB35-08-27-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169787858), received between Oct 9, 2020 and Jan 25, 2024 — classified as 1 injury, 3 malfunctions.

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 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 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LIMITED INFORMATION REPORTS THAT DURING A PROCEDURE INTENDING TO TREAT THE RIGHT ILIAC ARTERY USING A VISIPRO BALLOON EXPANDABLE STENT, THE STENT CAME OFF THE BALLOON SHAFT AND WAS DEPLOYED IN THE LEFT ILIAC TO AVOID MIGRATION. NO PATIENT CLINICAL SIGNS, SYMPTOMS OR CONDITIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581344 ↗
• MalfunctionNov 27, 2022Use of Device Problem; Use of Device Problem

  A VISIPRO STENT WAS IMPLANTED FOR THE TREATMENT OF AN UNKNOWN LESION IN THE PROXIMAL REGION OF THE COMMON ILIAC ARTERY. THERE WAS MODERATE CALCIFICATION AND NO TORTUOSITY. IT WAS REPORTED THAT THE IMPLANTED STENT WAS EXPIRED. IT WAS NOT KNOWN THAT THE STENT WAS EXPIRED PRIOR TO IMPLANTATION. IT WAS ACKNOWLEDGED AND NOTIFIED ONCE PROCEDURE WAS PERFORMED. SUCCESSFULLY IMPLANTED WITHOUT ANY ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15867185 ↗
• MalfunctionApr 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE THE VISI-PRO BALLOON EXPANDABLE STENT DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN THE PROXIMAL COMMON ILIAC ARTERY. THE VESSEL HAD SEVERE TORTUOSITY AND EXHIBITED 35-45% STENOSIS. THE ARTERY DIAMETER WAS 8-10MM AND LESION LENGTH WAS 25-40MM. A NON-MEDTRONIC 7FR SHEATH WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E., SHELF CARTON, HOOP/TRAY) AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A 7X40 MM PTA BALLOON. 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/AT LESION. THE VISI-PRO CAME UNCRIMPED FROM DELIVERY BALLOON. THE DISLODGED STENT WAS NOT REMOVED. THE STENT WAS RE-ACCESSED AND DEPLOYED IN HEALTHY RIGHT COMMON ILIAC ARTERY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14160665 ↗
• InjuryOct 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE A VISIPRO BALLOON EXPANDABLE STENT DURING PROCEDURE. DURING DELIVERY TO/AT LESION, STENT DISLODGEMENT OCCURRED. THE DISLODGED STENT WAS REMOVED. IT WAS REPORTED THAT VISIPRO STENT BECAME DISLODGED FROM THE BALLOON. THE STENT WAS RETRIEVED AND THE CASE WAS COMPLETED TO THE PHYSICIANS SATISFACTION. PATIENT WENT HOME THE SAME NIGHT. THE PHYSICIAN WAS INTENDING TO STENT AN OSTIA ILIAC LESION FROM THE IPSILATERAL SIDE. PHYSICIAN USED A 6FR 23CM AND NON-MEDTRONIC SHEATH TO ACCESS THE LESION AND VISUALIZE. THE LESION WAS MODERATELY CALCIFIED AND THE ILIAC SYSTEM WAS MODERATELY TORTUOUS. PHYSICIAN INSERTED THE VISIPRO STENT DELIVERY SYSTEM OVER AN UNKNOWN .035" WIRE AND DELIVERED THE STENT TO THE LESION SITE. PHYSICIAN DECIDED TO TAKE ANOTHER PICTURE AND, BECAUSE THE STENT DELIVERY SYSTEM WAS IN THE SHEATH, DECIDED TO REMOVE THE STENT DELIVERY SYSTEM WITH THE STENT UNDEPLOYED FROM THE PATIENT. WHEN PHYSICIAN TRIED TO WITHDRAW THE STENT INTO THE SHEATH, THE STENT BECAME SEPARATED AND THE CATHETER AND BALLOON WERE REMOVED OVER THE WIRE. THE UNEXPANDED STENT REMAINED OVER THE WIRE AND EITHER NEAR OR PARTIALLY IN THE DISTAL END OF THE SHEATH. PHYSICIAN MADE THE

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10657745 ↗