Visi-Pro™ PXB35-08-37-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169787889), received between Jan 2, 2020 and Oct 27, 2023 — classified as 3 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 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.

• InjuryOct 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT A VISI-PRO BALLOON EXPANDABLE STENT FOR TREATMENT OF A CALCIFIED LESION. THERE WAS MILD TORTUOSITY. THE POSTERIOR TIBIAL ARTERY (PT) DID NOT HAVE CHRONIC TOTAL OCCLUSION. A 6FR SHEATH AND A 035 GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THE STENT WAS STUCK IN THE PT  ARTERY AND NOT ON THE PTA CATHETER WHEN THE CATHETER ARRIVED AT THE DEPLOYMENT SITE. ACCESS WAS PEDAL WITH A SHORT 6F SHEATH. INTENDED STENT DEPLOYMENT SITE WAS THE COMMON FEM ARTERY. CATHETER REMAINED IN PATIENT LEG, AND WAS SURGICALLY REMOVED IN THE HOSPITAL AFTER THE STENT WAS RETRIEVED VIA CUT-DOWN. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18020897 ↗
• InjuryJun 10, 2020Burst Container or Vessel; Premature Activation; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Premature Activation; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A NON-MEDTRONIC 6FR SHEATH DURING TREATMENT OF A 37MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL RIGHT COMMON ILIAC ARTERY OF REPORTED DIAMETER 7MM. SEVER VESSEL CALCIFICATION IS REPORTED. LESION EXHIBITED 50% STENOSIS. 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. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. PRE-DILATION WAS PERFORMED USING 2.0 AND 4.0 PTA BALLOONS. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. ISSUES ARE REPORTED DURING STENT DEPLOYMENT. IT IS REPORTED AT AN INFLATION PRESSURE OF 10ATM ON FIRST INFLATION A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED LEADING TO PARTIAL DEPLOYMENT OF THE PROXIMAL TIP OF THE STENT. WHEN REMOVED, IT WAS OBSERVED A SMALL PORTION OF THE BALLOON HAD DETACHED ON THE WIRE. THE RADIOPAQUE MARKER WAS ALSO OBSERVED ON THE WIRE. THE STENT WAS THEN FULLY EXPANDED USING A CORONARY BALLOON FOLLOWED BY A PERIPHERAL BALLOON. THE PATIENT IS REPORTED TO HAVE REMAINED STAB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10137278 ↗
• InjuryApr 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A VISI PRO BALLOON EXPANDABLE STENT DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S PROXIMAL COMMON ILIAC ARTERY. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE LESION WAS NOT PRE-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. THE PROCEDURE WAS THEN COMPLETED USING A SELF-EXPANDING STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9971413 ↗
• MalfunctionJan 2, 2020Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  PHYSICIAN USED A VISI PRO BALLOON EXPANDABLE STENT WITH A 6FR SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL RIGHT COMMON ILIAC ARTERY OF DIAMETER 8MM. SLIGHT TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS NOT PERFORMED. MODERATE RESISTANCE WAS EXPERIENCED AND THE DEVICE WOULD NOT BE ADVANCED THROUGH THE LESION. THE VISI PRO WAS REMOVED. WHEN REMOVED, AN EVERCROSS BALLOON WAS USED TO PRE-DILATE THE LESION WITH SUCCESS . THE VISI PRO WAS THEN RE-INTRODUCED THE VISI PRO WAS THEN RE-INTRODUCED BUT THE STENT WAS OBSERVED TO HAVE COME LOOSE ON THE BALLOON WHILE ADVANCING THROUGH THE SHEATH, WHILE OUTSIDE THE BODY, AND PHYSICIAN DECIDED TO REMOVE THE ENTIRE SYSTEM. THE STENT APPEARED TO HAVE BECOME HUNG UP ON THE CROSS-CUT VALVE OF THE NON-MEDTRONIC SHEATH. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH A NEW VISI PRO TO COMPLETE THE PROCEDURE. NO INJURY REPORTED. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACULTY FOR EVALUATION, IT WAS NOTICED THAT THE DEVICE WAS DAMAGED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537797 ↗