Visi-Pro PXB35-07-27-135 (UDI 00643169787780)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169787780), received between May 26, 2020 and Mar 24, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE RENAL ARTERY USING THE VISI PRO STENT, THE PRONGS AT THE BACK OF THE STENT WERE OBSERVED "SPRINGING" OR "STICKING OUT" ONCE ADVANCED THROUGH THE SHEATH. THIS ISSUE WAS NOT PRESENT DURING DEVICE PREPARATION OR WHEN ADVANCING THE STENT INTO THE SHEATH OVER THE GUIDEWIRE, BUT WAS NOTICED AFTER THE STENT LEFT THE SHEATH INSIDE THE BODY AND TRAVELED INTO THE AORTA. THE PRONGS WERE DESCRIBED AS "BARELY" STICKING OUT, AND THE PHYSICIAN ELECTED TO PROCEED WITH DEPLOYMENT. THE STENT WAS DEPLOYED IN THE RENAL ARTERY, APPEARED WELL APPOSED, AND THE BALLOON CATHETER SYSTEM WAS REMOVED SAFELY. A 6FR NON MEDTRONIC SHEATH AND A 0.035" GUIDEWIRE WERE USED. FINAL PICTURES WERE TAKEN DURING THE PROCEDURE, AND NO ISSUES WERE OBSERVED DURING USE OR DEPLOYMENT. THE VESSEL WAS POST-DILATED USING THE BALLOON ON THE VISI PRO CATHETER. NO EMBOLIC PROTECTION WAS USED, AND THE VESSEL WAS NOT PRE-DILATED. THE PROCEDURE WAS COMPLETED WITHOUT INJURY OR INTERVENTION, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674265 ↗
• InjuryAug 26, 2025Fracture; Fracture

  MEDTRONIC PATIENT SERVICES RECEIVED A CALL ABOUT AN ISSUE WITH A VISIPRO STENT. IT WAS REPORTED THAT POST-OP, THE STENT IMPLANTED IN THE LEFT PULMONARY ARTERY (LPA) EXPERIENCED A FRACTURE. THE PATIENT IS SCHEDULED FOR A FOLLOW-UP PROCEDURE TO IMPLANT ANOTHER STENT IN ORDER TO REPAIR THE FRACTURED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892793 ↗
• MalfunctionJul 29, 2020Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A VISI PRO BALLOON EXPANDABLE STENT SYSTEM WITH A NON-MEDTRONIC 6FR SHEATH AND 0.035 WHOLEY WIRE DURING TREATMENT A 27MM CALCIFIED AND SOFT TISSUE LESION IN THE PATIENT¿S PROXIMAL LEFT SUBCLAVIAN ARTERY OF DIAMETER 7MM. SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. 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 DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED THE STENT BECAME DISLODGED DURING INSERTION THOUGH THE LESION PRIOR TO INFLATION DESPITE THERE BEING A SUFFICIENT DISTAL LANDING ZONE. THE STENT WAS INFLATED AND PLACED OUT OF POSITION IN AN UNINTENDED AREA. A SECOND STENT WAS USED TO TREAT THE AND PLACED TO BRIDGE THE LESION. THE SECOND STENT PLACED WAS USED TO TREAT THE LESION AND NOT CRUSH THE DISLODGED STENT. NO VESSEL DAMAGE WAS NOTED. NO ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT AND THERE ARE NO PLANS TO REMOVE THE DISLODGED STENT. THERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10336934 ↗
• InjuryMay 26, 2020Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Positioning Problem; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Positioning Problem

  PHYSICIAN INTENDED TO USE A VISI PRO BALLOON EXPANDABLE STENT SYSTEM WITH A NON-MEDTRONIC 6FR SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIES LESION IN THE PATIENT¿S PROXIMAL LEFT SUBCLAVIAN ARTERY. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 90% STENOSIS. NO DAMAGE NOTED TO PRODUCT PACKAGING PRIOR TO USE. NO ISSUE WAS NOTED WHEN REMOVING THE DEVICE FORM THE PACKAGING. DEVICE WAS PREPPED AS PER IFU. THE MODIFIED SELDINGER TECHNIQUE WAS USED. A (VERT) CATHETER WAS USED TO SELECTIVELY ENGAGE THE LEFT SUBCLAVIAN ARTERY. ANGIOGRAPHY WAS PERFORMED. HEPARIN WAS USED FOR ANTICOAGULATION. INTRAVASCULAR ULTRASOUND (IVUS) INTERROGATION OF THE LEFT SUBCLAVIAN WAS PERFORMED TO HELP GUIDE THE INTERVENTION. BY IVUS A NEAR TOTAL/SUB-TOTAL OCCLUSION WAS DESCRIBED. THE IVUS CATHETER WAS UNSUCCESSFUL IN CROSSING THE LESION. PRE-DILATION WAS PERFORMED USING A 3MM MEDTRONIC BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT, BUT IT IS REPORTED THE STENT COULD NOT PASS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN NOTED THE STENT WAS NOT ON THE BALLOON BUT HAD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10086747 ↗