Visi-Pro™ PXB35-07-17-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169787766), received between May 6, 2022 and Sep 16, 2024 — classified as 2 injuries, 2 malfunctions.

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.

• MalfunctionSep 16, 2024Use of Device Problem; Use of Device Problem

  LIMITED INFORMATION REPORTS AN EXPIRED VISIPRO STENT WAS IMPLANTED IN A PATIENT (B)(6) 2024). THE STENT WAS 17 DAYS PAST EXPIRY DATE (09 AUG 2024). THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO ISSUES WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223033 ↗
• InjuryJun 21, 2024Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A 6FR NON-MEDTRONIC SHEATH AND A 0.014¿ GUIDEWIRE DURING TREATMENT OF A CALCIFIED FIBROUS PLAQUE LESION IN THE PATIENT¿S PROXIMAL SUBCLAVIAN ARTERY. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER REPORTED AS 7MM. 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 NOT POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. TRACKING DIFFICULTY DURING INITIAL ADVANCEMENT WAS REPORTED. THE GUIDEWIRE WAS HYDRATED AT PREP. IT WAS REPORTED THE STENT CAME OFF THE DELIVERY SYSTEM UNDEPLOYED. THE PHYSICIAN ATTEMPTED TO SNARE THE STENT, HOWEVER THIS WAS UNSUCCESSFUL AND THE PATIENT HAD TO HAVE VASCULAR SURGERY TO REMOVE THE STENT. THE SURGERY WAS SUCCESSFUL AND THE STENT WAS REMOVED. PROCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581257 ↗
• MalfunctionApr 3, 2023Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT A VISI PRO BALLOON EXPANDABLE STENT FOR THE TREATMENT OF A 13MM CALCIFIED LESION WITH 85% STENOSIS IN THE CELIAC ARTERY. THE ARTERY WAS 7MM IN DIAMETER WITH MODERATE TORTUOSITY AND CALCIFICATION. A 6FR NON-MEDTRONIC SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE WERE USED. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE STENT DISLODGED DURING REMOVAL, FOLLOWING A FAILED DELIVERY. WIRE ACCESS WAS LOST ACROSS THE CELIAC LESION BEFORE THE STENT WAS IN POSITION. THE PHYSICIAN WAS THEN REMOVING THE STENT FOLLOWING THE FAILED DELIVERY IN ORDER TO RE-CROSS THE LESION WITH THE WIRE, THE STENT THEN BECAME STUCK IN THE SHEATH (STUCK ON HAEMOSTATIC VALVE). WHEN THE STENT WAS BEING PULLED OUT OF THE SHEATH THE STENT CAME OFF OF THE BALLOON. ANOTHER SHEATH AND STENT WERE USED TO COMPLETE THE CASE. THE LESION WAS NOT PRE-DILATED, DEVICE DID NOT PASS THROUGH A PRE-DEPLOYED STENT, NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, NO EXCESSIVE FORCE USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662439 ↗
• InjuryMay 6, 2022Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO BALLOON EXPANDABLE STENT ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT COMMON ILIAC ARTERY (CIA) AND TIBIAL/POPLITEAL TRUNK (TPT). THE VESSELDIAMETER AND LESION LENGTH ARE 7MM AND APPROXIMATELY 70MM RESPECTIVELY. THE VESSEL WAS MODERATELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE VESSEL WAS PRE DILATED WITH A 6MM PRE DILATION DEVICE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE WITH EXCESSIVE FORCE USED DURING DELIVERY. IT WAS REPORTED THAT PHYSICIAN PLACE A 7 X 57 VISI PRO IN ILIAC ARTERY VIA LEFT RADIAL APPROACH AND NEEDED TO EXTEND THE STENT SLIGHTLY. WHEN PHYSICIAN WAS ADVANCING THE 7 X 17 STENT IT WAS GETTING STUCK ON THE SHELF OF THE 7 X 57 STENT THAT WAS PREVIOUSLY PLACED. THE STENT MIGRATED DISTALLY INTO SFA AND EVENTUALLY TO POPLITEAL/TP TRUNK AND HAD NO CATHETERS THA

  Patient problems: Insufficient Information

  MAUDE report 14302107 ↗