Visi-Pro™ PXB35-05-17-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169787575), received between Dec 13, 2018 and Mar 18, 2026 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PRE-RENAL STENTING FOR LASER FENESTRATED ENDOVASCULAR AORTIC REPAIR IN A PATIENT, MULTIPLE ISSUES OCCURRED INVOLVING THE STENT VISI PRO 035. THE PROCEDURE TARGETED THE PROXIMAL RIGHT AND LEFT RENAL ARTERIES, WHICH EXHIBITED MINIMAL TORTUOSITY AND CALCIFICATION, WITH A VESSEL DIAMETER OF 4.8MM AND NO LESION STENOSIS. THE FIRST STENT DISLODGED DURING PREPARATION PRIOR TO INSERTION INTO THE PATIENT. A SECOND STENT DISLODGED DURING USE IN THE PATIENT BUT WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION. A THIRD STENT ALSO DISLODGED DURING USE IN THE PATIENT, AND A SNARE ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT. IN EACH INSTANCE, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE OUTCOMES, ILLNESSES, INFECTIONS, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629461 ↗
• InjuryMar 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PRE-RENAL STENTING FOR LASER FENESTRATED ENDOVASCULAR AORTIC REPAIR IN A PATIENT, MULTIPLE ISSUES OCCURRED INVOLVING THE STENT VISI PRO 035. THE PROCEDURE TARGETED THE PROXIMAL RIGHT AND LEFT RENAL ARTERIES, WHICH EXHIBITED MINIMAL TORTUOSITY AND CALCIFICATION, WITH A VESSEL DIAMETER OF 4.8MM AND NO LESION STENOSIS. THE FIRST STENT DISLODGED DURING PREPARATION PRIOR TO INSERTION INTO THE PATIENT. A SECOND STENT DISLODGED DURING USE IN THE PATIENT BUT WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION. A THIRD STENT ALSO DISLODGED DURING USE IN THE PATIENT, AND A SNARE ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT. IN EACH INSTANCE, A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS, COMPLICATIONS, ADVERSE OUTCOMES, ILLNESSES, INFECTIONS, OR DEATHS WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24626289 ↗
• MalfunctionJun 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION WITH SEVERE CALCIFICATION AND MODERATE TORTUOSITY IN A RENAL VESSEL, THE STENT PXB35-05-17-080 VISI PRO 035 DISLODGED DURING USE. A 7FR NON-MEDTRONIC SHEATH WAS USED. THE VESSEL WAS PRE-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. A RENAL VESSEL RUPTURE OCCURRED DURING DEPLOYMENT OF ANOTHER STENT. THE VISIPRO STENT WAS SAFELY REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION, AND A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157090 ↗
• MalfunctionAug 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO IMPLANT A VISIPRO BALLOON EXPANDABLE STENTS DURING TREATMENT OF A LESION IN THE PATIENTS RENAL ARTERY. MODERATE VESSEL TORTUOSITY IS REPORTED. EMBOLIC PROTECTION WAS NOT USED. 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 DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THIS ISSUE IS REPORTED FOR 2 VISIPRO BALLOON EXPANDABLE STENTS. PHYSICIAN DEPLOYED ONE DISLODGED STENT IN THE ILIAC ARTERY, BUT WAS SUPPOSED TO BE DEPLOYED IN RENAL ARTERY. PHYSICIAN RETRIEVED THE OTHER DISLODGED STENT WITHIN THE SHEATH. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498602 ↗
• InjuryApr 4, 2023Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT DURING TREATMENT OF A 15MM CALCIFIED LESION IN THE PATIENT¿S PROXIMAL RENAL ARTERY. MODERATE VESSEL CALCIFICATION AND LITTLE VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED 70-80% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. APPEARED TO BE TWO RENAL ARTERIES GOING TO THE LEFT RENAL AFTER FURTHER ANGIO. EMBOLIC PROTECTION WAS NOT USED. 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 DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 3MM X 20MM BALLOON. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. PHYSICIAN DID FEEL RESISTANCE WHEN ADVANCING THE DEVICE THROUGH A PREVIOUS DEPLOYED STENT IN THE LEFT COMMON ILIAC. IT IS UNKNOWN IF EXCESS FORCE, OR THE AMOUNT OF FORCE, WAS USED TO PASS THE VISI-PRO THROUGH THE PREVIOUSLY DEPLOYED STENT. IT IS REPORTED STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. DISLODGED STENT NOT REMOVED. STENT REMAINED ON THE WIRE AND MOVED FROM LEFT RENAL ARTERY TO LEFT EXTERNAL ILIAC. BA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672001 ↗
• InjuryOct 14, 2021Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  PHYSICIAN WAS ATTEMPTING TO USE A VISIPRO BALLOON EXPANDABLE STENT TO TREAT A LESION IN THE COMMON ILIAC ARTERY. 6FR SHEATH USED. NO EMBOLIC PROTECTION WAS USED. DEVICE PREPPED PER IFU WITH NO ISSUE NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. IT WAS REPORTED THAT THE INITIAL STENT (5MM) WOULD NOT CROSS THE INTENDED LESION. WHEN THE DELIVERY SYSTEM WAS REMOVED TO DILATE THE ARTERY IT WAS NOTED THE STENT WAS NO LONGER ON THE BALLOON. USING FLUOROSCOPY THEY IDENTIFIED THE STENT IN THE ILIAC ARTERY. THE PHYSICIAN CHOSE TO USE THE SECOND VISIPRO STENT TO JAIL THE DISLODGED STENT IN THE ILIAC. THE 7MM STENT WAS USED TO PIN THE 5MM STENT AGAINST THE VESSEL WALL. NO ALLEGED PRODUCT ISSUE WITH 7MM STENT. THE PROCEDURE WAS THEN COMPLETED WITHOUT TREATING THE INTENDED LESION AND WITH NO PATIENT HARM. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12632556 ↗
• InjuryAug 10, 2021Malposition of Device; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Malposition of Device; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE THE VISI-PRO BALLOON EXPANDABLE PERIPHERAL STENT DURING PROCEDURE TO TREAT THE MID LEFT RENAL ARTERY. THE LEFT RENAL ARTERY HAD A PREVIOUS NON MEDTRONIC STENT AND IMAGING SHOWED RESTENOSIS. THE PHYSICIAN WAS ATTEMPTING TO EXTEND THE STENTED SEGMENT BY PLACING THE 5 X 17MM VIS-PRO STENT. A NON-MEDTRONIC WIRE AND 6FR SHEATH WERE USED. THE SHEATH WAS PLACED IN THE EXISTING NON MEDTRONIC STENT. THE 5X17MM VISI-PRO STENT WAS LOADED ON THE WIRE AND PUSHED THROUGH THE 6FR SHEATH. THE STENT BECAME DISLODGED AND CAME OFF THE BALLOON. THE ATTEMPTS TO PUSH THE BALLOON INTO THE STENT WERE UNSUCCESSFUL. AN ATTEMPT WAS MADE TO SNARE THE STENT BUT WHILE THE SNARE GOT AROUND THE STENT THE STENT DEFORMED A LITTLE. IT WAS DECIDED TO COMPLETE THE PROCEDURE BY LEAVING THE STENT AND PLACING THE PATIENT ON ANTICOAGULANTS. THE UN-DEPLOYED STENT WAS LEFT DISTAL TO THE EXISTING STENT. THE PHYSICIAN MADE THE STATEMENT OF POSSIBLE RENAL INFARCTION OF THE LEFT KIDNEY BUT THIS IS UNCONFIRMED.

  Patient problems: Device Embedded In Tissue or Plaque; Unspecified Tissue Injury

  MAUDE report 12301215 ↗
• InjuryApr 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE VISIPRO BALLOON EXPANDABLE STENT ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT A NONE CALCIFIED PLAQUE LESION IN THE RIGHT PROXIMAL TO MID RENAL ARTERY WITH 50% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 20MM RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE BALLOON WAS NEVER INFLATED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING DELIVERY TO/AT LESION, STENT DISLODGEMENT OCCURRED. THE DISLODGED STENT WAS REMOVED USING A GOOSENECK SNARE KIT. THERE WAS SUFFICIENT DISTAL LANDING ZONE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT WHEN THE DEVICE WAS NOT ABLE TO CROSS THE LESION AFTER THE PRE DILATION WITH A 4X40X135 EVERCROSS, THE STENT CAME OFF OF THE BALLOON WHILE THE SYSTEM WAS BEING PULLED BACK. THE DILSODGED STENT WAS HALF IN THE RENAL ARTERY AND OTHER HALF IN THE AORTA. THE REMOVAL WAS SUCCESSFUL WITH THE SNARE AND A REPLACEMENT 5X17X80 VISIPRO STE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11641184 ↗
• InjuryJan 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE THE VISIPRO BALLOON EXPANDABLE STENT TO TREAT A SEVERLY CALCIFIED SEVERELY TORTOUS LESION IN THE COMMON ILIAC/RENAL ARTERY. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE STENT WOULD NOT CROSS INTO THE RENAL ARTERY. UPON REMOVAL OF THE DEVICE, THE STENT CAME OFF THE BALLOON AS IT WAS BEING RETRACTED INTO THE SHEATH. A CUTDOWN WAS PERFORMED TO REMOVE THE STENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8266331 ↗
• InjuryDec 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN ATTEMPTED TO USE A VISIPRO WITH A 6F 65 CM NON-MEDTRONIC SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE TO TREAT A 10-15MM FIBROUS AND MINIMALLY CALCIFIED LESION WITH 50% STENOSIS IN THE PROXIMAL LEFT SUBCLAVIAN ARTERY OF DIAMETER 5 MM. IT WAS REPORTED THAT UPON ADVANCING THE STENT TO THE LESION SITE A DISCREPANCY BETWEEN THE STENT END AND THE BALLOON END MARKERS WAS NOTICED. DUE TO THE MISALIGNMENT OF MARKERS AND INSECURITY OF STENT THE PHYSICIAN PULLED THE DEVICE AS A SINGLE UNIT DOWN WITH THE INTENTION OF REMOVING IT BUT THE STENT BECAME DISLODGED ON THE BALLOON DELIVERY SYSTEM AND FULLY DISLODGED IN THE ILIAC ARTERY THE PHYSICIAN WAS UNABLE TO EVEN PERFORM ¿OFF-TARGET¿ STENT AS THERE WAS NOT ENOUGH BALLOON INSIDE THE STENT TO ATTEMPT DEPLOYMENT. THE PHYSICIAN ACCESSED FROM THE CONTRALATERAL SIDE TO GET UP AND OVER TO SUCCESSFULLY SNARE THE DISLODGED STENT WITH A NON-MEDTRONIC SNARE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8159328 ↗