Visi-Pro PXB35-07-17-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684036389), received between Feb 13, 2018 and Oct 24, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K061566); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN USED A VISI PRO BALLOON EXPANDABLE STENT SYSTEM WITH A 7FR NON-MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE FOR TREATMENT OF A CALCIFIED 17MM, 60% STENOSED LESION IN THE PATIENT¿S PROXIMAL RIGHT COMMON ILIAC ARTERY. THE VESSEL DIAMETER WAS REPORTED TO BE 7MM. SLIGHT TORTUOSITY AND MODERATE CALCIFICATION WERE REPORTED. THE IFU WAS FOLLOWED DURING PREP AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE LESION WAS NOT PRE-DILATED. NO RESISTANCE WAS EXPERIENCED NOR EXCESSIVE FORCE USED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT WAS REPORTED THAT THE BALLOON BURST IMMEDIATELY UPON INFLATION (PRESSURE UNKNOWN). NO FRAGMENTS OF THE BALLOON WERE REPORTED TO HAVE EMBOLISED. THE STENT WAS POST-DILATED WITH A 7X40 EVERCROSS DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO ISSUE NOTED WHEN RETRACTING THE STENT DELIVERY SYSTEM. NO PATIENT INJURY WAS REPORTED..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999967 ↗
• InjuryJun 6, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PHYSICIAN USED A VISI PRO DEVICE WITH A NON-MDT 7FR 55CM SHEATH AND A NON-MDT .035 X 260CM ANGLED GUIDEWIRE TO TREAT AN 80% CALCIFIED AND STENOSED LEFT PROXIMAL SUBCLAVIAN ARTERY. MODERATE TORTUOSITY WAS REPORTED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EMBOLIC PROTECTION WAS USED. THE RIGHT GROIN WAS UTILIZED WITH A 7FR SHEATH AND .035X260 GUIDEWIRE. THE STENOSIS WAS NOT ABLE TO BE CROSSED WITH THE VISI PRO DEVICE. UPON REMOVING THE STENT FROM THE SUBCLAVIAN THE STENT BECAME DISLODGED AT THE DISTAL END OF THE SHEATH AND WAS FREE FLOATING IN THE ARTERY, WHILE STILL REMAINING ON THE WIRE. THE PHYSICIAN WAS ABLE TO CAREFULLY ADVANCE A .035 TRAILBLAZER ACROSS THE UNDEPLOYED STENT AND EXCHANGED THE WIRE FOR A NON-MDT .035"X260 WIRE. AN EVERCROSS 7X20 BALLOON WAS THEN ADVANCED INTO THE UNDEPLOYED STENT. THE STENT WAS NUDGED INTO PLACE AND THE EVERCROSS WAS USED TO SUCCESSFULLY REDEPLOY THE STENT AT 12 ATM AT THE LEFT SUBCLAVIAN STENOSIS. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AND HE WAS REPORTED TO HAVE BEEN SENT TO THE FLOOR IN A STAB

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7573403 ↗
• InjuryFeb 13, 2018Fracture; Fracture

  THE PHYSICIAN TREATED A 15MM MODERATELY CALCIFIED LESION IN THE PROXIMAL CELIAC ARTERY WITH A VISI-PRO BALLOON- EXPANDABLE STENT. THE ARTERY HAD A DIAMETER OF 7MM AND HAD LITTLE TORTOUOSITY. THE VISIPRO WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 7 FR SHEATH AND A NON-MEDTRONIC WIRE .014" X 300 CM. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. TWO WEEKS AFTER THE PROCEDURE, PATIENT COMPLAINED OF PAIN AND A FOLLOW CANNULATION OF THE ARTERY WAS PERFORMED. DURING THIS FOLLOW-UP VISIT, IT WAS NOTICED THAT THE IMPLANTED STENT HAD FRACTURED. THE COMPONENT EMBOLIZED IN THE VESSEL. THE BROKEN PART OF THE DEVICE WAS EXPLANTED USING A SNARE. THE PHYSICIAN OPTED FOR NO FURTHER TREATMENT. THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND WAS REFERRED TO A GI PHYSICIAN. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Pain; Patient Problem/Medical Problem

  MAUDE report 7269135 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K061566. One submission often covers many models, so check the product and lot details in each record.

• Z-1547-2008 · Jul 1, 2008 · Terminated
  ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PX
• Z-1548-2008 · Jul 1, 2008 · Terminated
  ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27