Visi-Pro™ PXB35-08-57-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169787902), received between Jul 30, 2020 and May 14, 2024 — classified as 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A 6FR SHEATH DURING TREATMENT OF THE PATIENT¿S COMMON ILIAC ARTERY. 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 IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THE PHYSICIAN STATED THEY INSERTED THE STENT THROUGH A 6 FRENCH SHEATH BUT THEN DECIDED TO REMOVE IT FROM THE PATIENT. WHEN PHYSICIAN REMOVED THE VISIPRO STENT DELIVERY SYSTEM THE STENT WAS NO LONGER ON THE BALLOON. STENT DISLODGEMENT DURING USE IN THE PATIENT WAS REPORTED. THE STENT REMAINS IN THE PATIENT. NO ATTEMPTS WERE MADE TO REMOVE THE STENT. THE PHYSICIAN INSERTED ANOTHER STENT AND CRUSHED THE DISLODGED VISIPRO STENT AGAINST THE ARTERY WALL. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19309876 ↗
• MalfunctionFeb 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A VISIPRO STENT TO TREAT A CALCIFIED LESION IN THE PROXIMAL ILIAC ARTERY - COMMON. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS SEVERE. A 6FR TERUMO DESTINATION WAS USED. A .035 GLIDEWIRE ADVANTAGE WAS USED. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED PER IFU. THE LESION WAS PRE-DILATED WITH A 8MM X 40MM MUSTANG PTA. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. STENT DISLODGEMENT OCCURRED, DURING REMOVAL FOLLOWING FAILED DELIVERY. STENT WAS REMOVED IN CONJUNCTION WITH 6FR 45CM SHEATH. MANUAL PRESSURE ON ACCESS SITE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18674700 ↗
• InjuryJul 30, 2020Burst Container or Vessel; Device Damaged by Another Device; Material Deformation; Burst Container or Vessel; Device Damaged by Another Device; Material Deformation

  PHYSICIAN INTENDED TO USE A VISIPRO BALLOON EXPANDABLE STENT SYSTEM WITH A NON-MEDTRONIC 7FR SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 50MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL RIGHT COMMON ILIAC ARTERY. VESSEL DIAMETER REPORTED AS 8MM MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 99% 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. VESSEL PRE-DILATION WAS PERFORMED USING A 4MM PRE-DILATION DEVICE. THE STENT IS REPORTED TO HAVE BEEN PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED THAT STENT DEFORMATION DURING DEPLOYMENT OCCURRED. IT IS REPORTED THE STENT BECAME STUCK ON THE BALLOON WHICH LEAD TO THE DEFORMATION. THE BALLOON RUPTURED DURING THIS. 57MM OF THE STENT IS REPORTED TO HAVE DEPLOYED IN THE VESSEL. THE DEFORMED PORTION OF THE STENT WAS ANGIOPLASTIED USING A 4MM BALLOON AND A SECOND VISIPRO STENT WAS PLACED AT THE AREA OF DEFORMATION. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10343309 ↗