Visi-Pro™ PXB35-06-17-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169787674), received between Aug 15, 2023 and Jun 16, 2025 — classified as 1 injury, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LIMITED INFORMATION REPORTED THAT DURING A PROCEDURE INVOLVING THE STENT PXB35-06-17-135 VISI PRO 035, THE STENT DISLODGED DURING USE IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211827 ↗
• InjuryAug 15, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A 7FR NON-MEDTRONIC SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 15MM CALCIFIED LESION IN THE PATIENT¿S RIGHT DISTAL COMMON ILIAC ARTERY. MODERATE VESSEL CALCIFICATION AND MODERATE VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 8MM. 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. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. BALLOON INFLATION DIFFICULTIES AT 8 ATM DURING STENT DEPLOYMENT ARE REPORTED. THE STENT WAS BEING DEPLOYED IN THE ILIAC ARTERY BUT WOULD NOT HOLD PRESSURE. STENT DEPLOYED BUT WAS NOT FULLY EXPANDED DUE TO BALLOON LEAKING. STENT CATHETER WAS REMOVED AND A 6MM X 20MM EVERCROSS WAS INSERTED AND INFLATED TO 10 ATM TO FULLY EXPAND STENT. PROCEDURE COMPLETED WITH NO OTHER ISSUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547674 ↗