Visi-Pro™ PXB35-05-12-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169787568), received between Oct 12, 2020 and Oct 12, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2020Malposition of Device; Device Dislodged or Dislocated; Positioning Problem; Malposition of Device; Device Dislodged or Dislocated; Positioning Problem

  PHYSICIAN INTENDED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A 6FR NON-MEDTRONIC SHEATH AND 0.014 GUIDEWIRE DURING TREATMENT OF A 12MM PLAQUE LESION IN THE PATIENT¿S PROXIMAL RENAL ARTERY. SLIGHT VESSEL CALCIFICATION AND MODERATE TORTUOSITY ARE REPORTED. ARTERY DIAMETER REPORTED AS 5MM. LESION EXHIBITED 60-65% STENOSIS. IT IS REPORTED THE PATIENT¿S RENAL ARTERY HAD A GOOD DROP OFF FROM AORTA (DIPPED DOWN) BEFORE IT WAS STRAIGHT ANATOMY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE 0.014 WIRE WAS USED TO CROSS THE LESION AND PRE-DILATION WAS PERFORMED WITH A 3X12 CORONARY BALLOON. AN ATTEMPT WAS MADE TO CROSS WITH AN 0.035 WIRE BUT WAS UNSUCCESSFUL DUE TO THE ANGLES OF THE SHEATH AND ANATOMY. THE PHYSICIAN SWITCHED BACK TO THE 0.014 WIRE. THE STENT WAS THEN UNABLE TO CROSS DUE TO THE ANGLE COMING OFF THE AORTA AND THERE WAS NOT ENOUGH WIRE SUPPORT FOR AN 0.035 STENT SYSTEM PASSING OVER A 0.014 WIRE. ONCE THE PHYSICIAN MADE AN ATTEMPT TO CROSS, THE STENT IS REPORTED TO HAVE COME OFF THE BALLOON AND S

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10661229 ↗