Visi-Pro™ PXB35-07-57-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169787810), received between Jan 29, 2021 and Jul 31, 2025 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE VISI PRO 035, THE BALLOON BURST. THE RUPTURED BALLOON HAD TO BE SNARED OUT, AND BALLOON DETACHMENT OCCURRED DURING THE EVENT. ALL BALLOON FRAGMENTS WERE RETRIEVED FROM THE VESSEL. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675638 ↗
• MalfunctionJul 16, 2025Difficult to Insert; Compatibility Problem; Material Deformation; Difficult to Insert; Compatibility Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT PXB35-07-57-080 VISI PRO 035 WAS INTENDED TO BE USED TO TREAT PLAQUE IN THE LEFT PROXIMAL COMMON ILIAC ARTERY. DURING THE PROCEDURE, THERE WERE DIFFICULTIES INSERTING THE DEVICE, AND MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING IT. IT WAS STUCK, DIFFICULT TO PUSH FORWARD OR PULL BACK ON THE WIRE, SO THE PHYSICIAN COULD NOT GET IT OUT OF THE PATIENT. THE PHYSICIAN HAD TO PULL THE ENTIRE VISIPRO OUT WITH THE TERUMO SHEATH WITH NO ADDITIONAL INTERVENTION REQUIRED TO REMOVE. THE VESSEL WAS PRE-DILATED WITH A NON-MEDTRONIC 7X60X80 DILATION DEVICE, THE ARTERY DIAMETER WAS MEASURED AT 7MM, AND THE DEGREE OF TORTUOSITY WAS ASSESSED AS MODERATE. A 45CM 6FR NON-MEDTRONIC SHEATH AND A 180CM NON-MEDTRONIC GUIDEWIRE WERE USED. THE PROCEDURE WAS COMPLETED USING A NEW EVERFLEX 8X80X120 DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE STENT WAS DAMAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517234 ↗
• InjuryOct 18, 2023Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A 45CM 6FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A 25MM CALCIFIED LESION IN THE PATIENT¿S LEFT MID COMMON ILIAC ARTERY. SEVERE VESSEL CALCIFICATION AND MODERATE VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED 70-80% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. EMBOLIC PROTECTION WAS NOT USED. 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 WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT WAS PARTIALLY RETRIEVED USING A 10 AND 15MM SNARE. NEXT, BALLOON ANGIOPLASTY WAS PERFORMED OF THE LEFT COMMON ILIAC ARTERY USING 3.0X25 AND 5.0X20 MM BALLOONS TO CRUSH THE STENT TO THE LEFT COMMON ILIAC WALL. THE PATIENT WILL BE BROUGHT BACK AT A FUTURE DATE FOR A STENT TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17955142 ↗
• InjuryJan 29, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE INPACT ADMIRAL PACLITAXEL ELUTING STENT AND VISIPRO BALLOON EXPANDABLE STENT DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL COMMON ILIAC ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH WERE 7MM AND 57MM RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED WITH A 6MM X 100MM DEVICE. THE DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT DISLODGED (DISMOUNTED) FROM THE BALLOON AND THE DISTAL EDGE OF THE STENT DETACHED AND REMAINED NEXT TO THE ARTERIAL WALL. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE SMALL PIECE OF STENT THAT WAS DETACHED. THE PHYSICIAN ATTEMPTED TWO VISIPRO STENTS (7 X 37) AND THEY DISLODGED DURING ADVANCEMENT TO THE TARGET VESSEL. PHYSICIAN WAS ADVANCING THE STENTS THROUGH THE RIGHT COMMON FEMORAL ACCESS, THROUGH PREVIOUSLY PLACED STENTS IN THE RIGHT ILIAC SYSTEM, ACROSS THE BIFURCATION OF THE LEFT ILIAC. THE LEFT ILIAC WAS THE TARGET LESION. THE TWO VISIPRO DISLODGED STENTS WERE IMPLANTED IN AN

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11251698 ↗