Visi-Pro™ PXB35-09-27-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169787940), received between Apr 1, 2022 and Feb 24, 2023 — classified as 2 injuries.

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.

• InjuryFeb 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID RIGHT COMMON ILIAC ARTERY. MODERATE VESSEL CALCIFICATION AND MODERATE VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED 85% STENOSIS. 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 PRE-DILATED WITH A 5MM DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. A SNARE WAS USED TO REMOVE STENT AND ANOTHER VISIPRO STENT WAS DELIVERED AND SUCCESSFULLY DEPLOYED. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16434973 ↗
• InjuryApr 1, 2022Malposition of Device; Malposition of Device

  PHYSICIAN WAS ATTEMPTING TO USE THE VISI PRO BALLOON EXPANDABLE STENT DURING PROCEDURE TO TREAT RIGHT COMMON ILIAC ARTERY. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY) AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THE STENT WAS DETACHED FROM THE CATHETER. IT IS BELIEVED THAT THE STENT CAME OFF THE CATHETER BECAUSE THE DOCTOR DID NOT CORRECTLY PREP THE VESSEL AND IT WAS TOO TIGHT OF A SPACE. THE STENT WAS PLACED IN THE RIGHT INNOMINATE ARTERY. THE DOCTOR DID GO IN FROM THE OTHER SIDE AND SNARED THE STENT AND PULLED IT INTO THE CORRECT POSITION. PHYSICIAN THEN ANGIOPLASTIED IT GIVING THE OUTCOME WANTED. NO OTHER STENT WAS USED. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13974562 ↗