Visi-Pro™ PXB35-08-17-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169787834), received between Aug 5, 2020 and Feb 20, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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.

• MalfunctionFeb 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A VISIPRO STENT TO TREAT A LESION. IT WAS REPORTED THAT LESION WAS AT THE OSTIUM OF THE RIGHT PROXIMAL RENAL ARTERY AND EVALUATED TO 80% STENOSIS. CALCIUM AND TORTUOSITY WAS MINIMAL. EMBOLIC PROTECTION WAS NOT USED. THE PHYSICIAN USED A 6FR 45 CM NON-MEDTRONIC SHEATH TO ENGAGE THE RENAL. A 0.035 X 260 NON-MEDTRONIC WIRE WAS USED TO DELIVER THE INTERVENTIONAL EQUIPMENT.   PRE DILATATION WAS PERFORMED WITH A 6 X 20 NON-MEDTRONIC BALLOON. POST DILATATION WAS PERFORMED WITH A 7X20 NON-MEDTRONIC BALLOON. IT WAS REPORTED THAT STENT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED BY CAPTURING IN SHEATH. THERE WAS REMOVAL DIFFICULTIES. THE DELIVERY CATHETER CAUGHT ON STENT UPON WITHDRAWAL. THE CASE WAS COMPLETED WITH A 6 X 17 X 80 VISIPRO THAT WAS POST DILATED WITH THE 7 X 20 BALLOON. THE CASE WAS COMPLETED WITHOUT COMPLICATION AND THE PATIENT WAS DISCHARGED THE SAME DAY WITHOUT ANY COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404047 ↗
• MalfunctionSep 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO BALLOON EXPANDABLE STENT ALONG WITH A NON-MEDTRONIC 6FR SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT A LESION IN THE DISTAL AORTA. THE VESSEL WAS NONE TORTUOUS. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT DURING DELIVERY TO LESION, STENT DISLODGEMENT OCCURRED. STENT MOVED ON BALLOON WHEN IT CAME OUT OF THE SHEATH. IT WAS NOT COMPLETELY OFF THE BALLOON SO PRODUCT WAS PULLED BACK THROUGH SHEATH AND ANOTHER STENT WAS PULLED TO COMPLETE THE PROCEDURE. THE PATIENT WAS PEDIATRIC. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354907 ↗
• MalfunctionAug 5, 2020Premature Activation; Malposition of Device; Device Dislodged or Dislocated; Premature Activation; Malposition of Device; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A NON-MEDTRONIC 6FR SHEATH DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S MID COMMON ILIAC ARTERY. SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. 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 DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED DURING ADVANCEMENT, BUT NO EXCESSIVE FORCE WAS USED. INACCURATE DELIVERY IS REPORTED. IT IS REPORTED THAT THE STENT DEPLOYED BEFORE REACHING THE TARGET LESION. THERE WAS SUFFICIENT DISTAL LANDING ZONE. A STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10366391 ↗