Visi-Pro™ PXB35-06-37-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169787704), received between Dec 8, 2020 and Dec 8, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2020Difficult to Remove; Deformation Due to Compressive Stress; Positioning Problem; Difficult to Remove; Deformation Due to Compressive Stress; Positioning Problem

  PHYSICIAN INTENDED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A NON-MEDTRONIC 6FR SHEATH DURING TREATMENT OF THE PATIENT¿S MID COMMON ILIAC ARTERY. SLIGHT VESSEL TORTUOSITY IS REPORTED. 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. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STET. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT IS REPORTED STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/PLACEMENT. WHILE ADVANCING STENT THROUGH SHEATH OVER THE BIFURCATION IT BECAME STUCK AND APPEARED TO KINK UNDER FLUOROSCOPY. IT IS REPORTED DIFFICULTY WAS ENCOUNTERED REMOVING THE DEVICE PRIOR TO STENT DEPLOYMENT. PHYSICIAN DECIDED TO REMOVE STENT, BUT THE STENT BECAME CAUGHT ON SHEATH WHILE REMOVING. THE DELIVERY CATHETER DID NOT CATCH ON STENT UPON WITHDRAWAL. THE DEVICE WAS SUCCESSFULLY REMOVED. STENT STRUTS' WERE NEVER EXPOSED WITHIN THE PATIENT AS IT NEVER LEFT THE SHEATH. NO INTERVENTION WAS REQUIRED FOR DEVICE REMOVAL AS PHYSICIAN WAS ABLE TO PULL BACK OUT OF THE SHEATH. A REPLACEMENT STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968659 ↗