Visi-Pro™ PXB35-07-27-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169787773), received between Dec 19, 2018 and Nov 6, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 16, 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.

• MalfunctionNov 6, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A VISIPRO STENT WAS USED TO TREAT A CALCIFIED PLAQUE LESION IN THE LEFT PROXIMAL ILIAC ARTERY - COMMON. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS MODERATE.  LESION STENOSIS WAS 80%. A 6FR TERUMO 11 CM SHEATH FRENCH WAS USED. A 035 CORDIS STORQ WIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED PER IFU. THE LESION WAS PRE-DILATED WITH A 5/40 DEVICE.  THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE VISIPRO STENT WAS EXPIRED WHEN IMPLANTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18071738 ↗
• InjuryJan 20, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE VISI-PRO BALLOON EXPANDABLE STENT DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN PROXIMAL BILIARY ARTERY. THE VESSEL HAD MODERATE TORTUOSITY AND EXHIBITED 75% STENOSIS. THE ARTERY DIAMETER WAS 6.5MM AND LESION LENGTH WAS 24MM. A NON-MEDTRONIC 7FR SHEATH AND 0.035X260CM GUIDEWIRE WERE USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. A 5MMX29MM EVERCROSS PTA BALLOON WAS USED FOR PRE-DILATION. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE. THE STENOSIS IN THE SUPERIOR MESENTERIC ARTERY WAS CROSSED WITH A NON-MEDTRONIC WIRE. IMAGES WERE TAKEN AND THE PHYSICIAN DECIDED TO PRE-DILATE THE LESION WITH A 5MM BY 20MM EVERCROSS PTA BALLOON. IMAGES WERE RE-TAKEN WITH NO ISSUES. THE PHYSICIAN CHOSE A 7X27 VISI-PRO STENT. THE STENT WAS FLUSHED PER IFU AND WAS PLACED IN POSITION IN THE PROXIMAL SUPERIOR MESENTERIC ARTERY. THE VISI-PRO STENT WAS INFLATED TO NOMINAL SIZE AT 10 ATM. IT WAS REPORTED THAT THE BALLOON RUPTURED AT 10 ATM AND A PIECE OF THE BALLOON REMAINED ON THE WIRE. THE REMAINDER OF THE BALLOON WAS REMOVED. ATTEMPTS WERE MA

  Patient problems: Insufficient Information

  MAUDE report 13305107 ↗
• MalfunctionSep 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A VISI PRO STENT WAS ATTEMPTED TO BE USED WITH A 7FR NON-MEDTRONIC SHEATH AND .035 WIRE DURING TREATMENT OF A 30MM CALCIFIED LESION IN THE PATIENT¿S MID LEFT COMMON ILIAC ARTERY OF DIAMETER 7MM. SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 99% STENOSIS. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING ATTEMPTED REMOVAL FOLLOWING FAILED DELIVERY. THE STENT STRUT IS REPORTED TO HAVE BECOME CAUGHT ON THE SHEATH TIP WHEN ATTEMPTING TO REMOVED. THIS RESULTED IN THE STENT BECOMING DISLODGED FROM THE BALLOON. THE BALLOON WAS ADVANCED BACK THROUGH THE STENT AND DEPLOYED IN THE EXTERNAL ILIAC ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9103736 ↗
• MalfunctionMar 20, 2019Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A VISIPRO WITH A NON-MEDTRONIC 6FR SHEATH (CORDIS) AND 0.035 GUIDEWIRE (MAGIC TORQUE) TO TREAT A PLAQUE LESION WITH 90% STENOSIS IN THE LEFT PROXIMAL RENAL ARTERY. THE ARTERY DIAMETER WAS 7MM AND THE VESSEL PRESENTED MODERATE TORTUOSITY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED DIFFICULTY WHEN ATTEMPTING TO CROSS THE STENOSIS. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS USED TO PRE-DILATE THE VESSEL. ON SECOND ATTEMPT, THE STENT COULD NOT MAKE THE 90 DEGREE TURN, SO THE CATHETER WAS REMOVED. A 6X17 STENT WAS USED AND DURING INSERTION. A SHADOW WAS NOTED ON THE GUIDEWIRE. THE PREVIOUSLY USED STENT CATHETER WAS CHECKED AND THE STENT WAS MISSING. IN THE PROCESS OF PULLING THE WIRE BACK, THE STENT CAME OFF THE WIRE AND WAS FREE FLOATING IN THE AORTA. AN AMPLATZ SNARE WAS INSERTED AND REMOVED THE STENT IN ITS ENTIRETY. THE PROCEDURE WAS NOT COMPLETED. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY, IT WAS NOTED THAT THE STENT WAS DAMAGED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8435821 ↗
• InjuryDec 19, 2018Unintended Ejection; Detachment of Device or Device Component; Unintended Ejection; Detachment of Device or Device Component

  THE PHYSICIAN ATTEMPTED TO USE A VISIPRO WITH A NON-MEDTRONIC 6FR SHEATH AND A 0.035 GUIDEWIRE TO TREAT A PLAQUE LESION WITH 90% STENOSIS IN THE LEFT PROXIMAL RENAL ARTERY. THE ARTERY DIAMETER WAS 7MM AND THE VESSEL PRESENTED MODERATE TORTUOSITY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED DIFFICULTY WHEN ATTEMPTING TO CROSS THE STENOSIS. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS USED TO PRE-DILATE THE VESSEL. ON THE SECOND ATTEMPT, THE STENT COULD NOT MAKE THE 90 DEGREE TURN AND THE CATHETER WAS REMOVED. ANOTHER 6X17 STENT WAS USED AND DURING INSERTION A SHADOW WAS NOTED ON THE GUIDEWIRE. THE PREVIOUSLY USED STENT CATHETER WAS CHECKED AND THE STENT WAS MISSING. IN THE PROCESS OF PULLING THE WIRE BACK, THE STENT CAME OFF THE WIRE AND WAS FREE FLOATING IN THE AORTA. AN AMPLATZ SNARE WAS INSERTED AND REMOVED THE STENT IN ITS ENTIRETY. THE PROCEDURE WAS NOT COMPLETED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8178526 ↗