Visi-Pro™ PXB35-07-37-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169787803), received between Feb 22, 2019 and Sep 2, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING DELIVERY OF THE STENT VISI PRO 035 TO THE LESION IN THE RIGHT MID COMMON ILIAC ARTERY, WHICH HAD 80% STENOSIS AND SEVERE CALCIFICATION, STENT DISLODGEMENT OCCURRED. THE STENT DISLODGMENT OCCURED IN THE BRACHIAL ARTERY AT THE ACCESS SITE AND WAS REMOVED BY PULLING IT OUT WITH THE SHEATH. THE LESION WAS NOT PRE-DILATED, NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING FEMORAL ACCESS, AND TWO VISI PRO STENTS WERE SUCCESSFULLY DEPLOYED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931923 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A VISI-PRO STENT AND A EVERFLEX ENTRUST STENT WAS USED TO TREAT THE COMMON ILIAC, EXTERNAL ILIAC. APPROXIMATELY 7 MONTHS POST PROCEDURE PATIENT SUFFERED CRITICAL RIGHT LIMB ISCHEMIA. PATIENT PRESENTED WITH RESTING ANKLE-BRACHIAL INDEX (ABI) OF 0.4 ON THE RIGHT WITH WORSENING SYMPTOMS OF ISCHEMIA. PATIENT UNDERWENT ANGIOPLASTY AND STENTING WITH A MEDTRONIC STENT TO THE TARGET LESION. PATIENT RECOVERED.

  Patient problems: Ischemia

  MAUDE report 21761588 ↗
• InjuryApr 8, 2024Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A 6FR X 10CM NON-MEDTRONIC SHEATH AND A .035 X 260MM NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 30MM CALCIFIED LESION IN THE PATIENT¿S LEFT MID COMMON ILIAC ARTERY. MODERATE VESSEL CALCIFICATION WAS REPORTED. LESION EXHIBITED 90% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. 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. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH AN 5X60 EVERCROSS PTA BALLOON. THE VESSEL WAS NOT POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED STENT DISLODGEMENT OCCURRED DURING PROCEDURE TO PUT KISSING VISI-PRO STENT AT COMMON ILIAC ARTERY IN THE PATIENT. THE RIGHT ILIAC STENT WENT UP WITH NO ISSUES. WHEN THE LEFT ILIAC STENT WAS ATTEMPTED TO BE MOVED INTO PLACE. A LITTLE RESISTANCE WAS FELT, BUT STE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057619 ↗
• MalfunctionJul 30, 2020Malposition of Device; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Malposition of Device; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A VISI PRO BALLOON EXPANDABLE STENT SYSTEM WITH A NON-MEDTRONIC 6FR SHEATH AND 0.035 NON-MEDTRONIC WIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID COMMON ILIAC ARTERY. SLIGHT VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. LESION PRE-DILATION WAS PERFORMED WITH A 7MM NON-MEDTRONIC DEVICE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS NOTED DURING ADVANCEMENT. THERE WAS SUFFICIENT DISTAL LANDING ZONE, HOWEVER IT IS REPORTED THE STENT DEPLOYED ABOVE THE INTENDED LANDING AREA. A SECOND VISI PRO STENT WAS PLACED TO COMPLETE THE CASE. THE SECOND STENT WAS NOT PLANNED FOR. IT WAS IMPLANTED TO TREAT THE AREA THAT WAS INITIALLY INTENDED TO COVER WITH THE FIRST STENT TO COVER THE TARGET LESION. NO ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT. NO VESSEL DAMAGE WAS NOTED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10342722 ↗
• InjuryFeb 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A VISIPRO STENT TO TREAT A LESION IN THE ILIAC ARTERY ¿ COMMON IN A PATIENT WITH MODERATE CALCIFICATION AND TORTUOSITY AND 80% STENOSIS. A NON-MEDTRONIC 6FRX45CM (TERUMO) SHEATH AND .014X 300 (HALBERD) WIRE WERE ALSO USED. NO DAMAGE NOTED TO PACKAGING NOTED, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DEVICE WAS PREPPED AS PER IFU. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT NO EXCESSIVE FORCE WAS REQUIRED. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO/AT LESION; THE VISIPRO WAS INFLATED WITH A NANOCROSS AFTER IT CAME OFF THE BALLOON. A NON-MEDTRONIC GUIDE CATHETER WAS USED TO PUSH STENT DOWN INTO POSITION. THIS WAS THEN FOLLOWED BY ANOTHER NANOCROSS, AND AN EVERCROSS TO EXPAND THE STENT. IMPLANTED ANOTHER VISIPRO AT THE LESION SITE. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361712 ↗