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

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169787759), received between Aug 5, 2020 and Feb 16, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Use of Device Problem

  IT WAS REPORTED THAT AN EXPIRED VISI PRO 035 WAS IMPLANTED, WITH THE EXPIRATION DATE BEING JANUARY 8, 2026, AND THE EXPIRATION DATE WAS NOT CHECKED PRIOR TO IMPLANTATION. THE STENT WAS PLACED IN A VESSEL WITH A DIAMETER OF 7MM. NO SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, OR INJURIES WERE REPORTED. THE STENT REMAINED IN USE AND WAS NOT REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343567 ↗
• InjuryJan 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE USE OF A VISI PRO STENT 035 IN THE LEFT SUBCLAVIAN ARTERY, THE STENT BECAME DISLODGED. THE PHYSICIAN INTERVENED BY USING A BALLOON TO DRAG THE UNDEPLOYED STENT BACK INTO THE SHEATH, SUCCESSFULLY REMOVING IT IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY. THE PROCEDURE WAS COMPLETED USING A NEW VISI PRO DEVICE FROM THE CONSIGNMENT INVENTORY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093487 ↗
• MalfunctionMay 4, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO BALLOON EXPANDABLE STENT ALONG WITH A NON-MEDTRONIC 6FR SHEATH DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT BILIARY ARTERY AND COMMON ILIAC ARTERY. THE VESSEL WAS LITTLE TORTUOUS. NO EMBOLIC PROTECTION USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICES FROM HOOP/TRAY. THE DEVICES WERE PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE FIRST VISI PRO WAS INACCURATELY DELIVERED (THAT IS, STENT DEPLOYED IN UNINTENDED LESION SITE). THERE WAS SUFFICIENT LANDING ZONE. THE STENT WAS FULLY EXPANDED. IT CAME OFF THE BALLOON AT THE EXTERNAL ILIAC EN ROUTE TO THE RENAL ARTERY. IT WAS THEN DEPLOYED IN THIS POSITION. THERE WAS AN ATTEMPT MADE TO REMOVE THE STENT. IT IS UNKNOWN IF THERE WAS DEFORMATION NOTED ON THE STENT. THE LESION WAS NOT PRE DILATED. THE FIRST DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE USED. ANOTHER STENT WAS SELECTED, PXB35-07-17-080, DELIVERED TO TARGET LESION AND DEPLOYED. THE SECOND VISI PRO, BALLOON DEFLATION DIFFICULTIES OCCURRED WITH THE DEVICE SLOW TO DEFLATE AT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14276427 ↗
• InjuryMar 24, 2021Device 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 BILIARY ARTERY. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED DURING REMOVAL OF THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS NOT ADVANCED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY OF THE STENT TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED USING A SNARE. NO HARM REPORTED TO THE PATIENT. THE PROCEDURE WAS COMPLETED BY PREDILATING WITH AN 4X20 EVERCROSS BALLOON AND PLACING ANOTHER VISIPRO STENT. NO FURTHER INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11561848 ↗
• InjuryJan 14, 2021Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  PHYSICIAN WAS ATTEMPTING TO USE VISIPRO BALLOON EXPANDABLE STENT ALONG WITH A NON-MEDTRONIC 6FR SHEATH DURING PROCEDURE TO TREAT A NONE CALCIFIED SOFT TISSUE LESION IN THE LEFT MID RADIAL TO SUBCLAVIAN ARTERY. 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. STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE PATIENT WAS TAKE TO OR WHERE THE STENT WAS SURGICALLY REMOVED. THE DISLODGED STENT WAS REMOVED. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT PHYSICIAN WAS TREATING A BLOCKAGE OF THE LEFT SUBCLAVIAN ARTERY AT THE OSTIUM FROM A RADIAL APPROACH. UPON DELIVERING THE VISIPRO STENT, PHYSICIAN BELIEVED SITE WAS IN A DISSECTION PLANE AND DECIDED TO REMOVE THE STENT AND DELIVERY SYSTEM. PHYSICIAN SPECULATED THE WIRE HAD TRAVELLED INTO DISSECTION PLANE OF ARTERY. WHEN THE DELIVERY SYSTEM WAS OUT OF THE SHEATH, THE STENT WAS NO LONGER ON IT. FLUOROSCOPY SHOWED THE STENT AT THE JUNCTION OF THE ELBOW IN

  Patient problems: Obstruction/Occlusion

  MAUDE report 11168680 ↗
• 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. 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. LESION PRE-DILATION WAS NOT PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. INACCURATE DELIVERY IS REPORTED. IT IS REPORTED THAT THE STENT DEPLOYED BEFORE REACHING THE TARGET LESION. THERE WAS SUFFICIENT DISTAL LANDING ZONE. A SECOND STENT WAS DEPLOYED OVER IT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10366390 ↗