Visi-Pro™ PXB35-09-27-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169787933), received between Mar 12, 2021 and Apr 30, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 30, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT DURING PATIENT TREATMENT. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). A BALLOON BURST/LEAK WAS REPORTED DURING STENT DEPLOYMENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214070 ↗
• MalfunctionOct 6, 2022Use of Device Problem; Use of Device Problem

  A PHYSICIAN WAS USING A VISI-PRO BALLOON-EXPANDABLE PERIPHERAL STENT SYSTEM FOR TREATMENT OF AN UNKNOWN LESION IN THE LEFT SUBCLAVIAN ARTERY. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE STENT WAS IMPLANTED AS THE ACCOUNT BELIEVED SINCE SEPTEMBER WAS LISTED AS THE EXPIRATION MONTH THAT ALL INVENTORY EXPIRED AT THE END OF THE MONTH. THE WAS NO PATIENT INJURY AND THE STENT REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15551152 ↗
• MalfunctionMar 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A 7FR NON-MEDTRONIC SHEATH AND 0.035 GUIDEWIRE DURING TREATMENT OF A 22MM LESION IN THE PATIENT¿S PROXIMAL COMMON ILIAC ARTERY. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. ARTERY DIAMETER REPORTED AS 9MM. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. PRE-DILATION WAS PERFORMED USING A 8X40 PRE-DILATION DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCE OF THE DEVICE. IT IS REPORTED THE STENT DISLODGED WHILE GOING THROUGH THE 7FR SHEATH. THE STENT AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AT SAME TIME. A SECOND VISIPRO WAS OPENED AND DEPLOYED IN TARGET AREA TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11472005 ↗