Visi-Pro™ PXB35-08-57-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169787896), received between Jun 22, 2022 and Jan 26, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE VISI PRO 035, THERE WAS A DELAY IN SURGERY OF 10 MINUTES DUE TO PARTIAL DEPLOYMENT OF THE DEVICE AT THE TARGET SITE WITHIN THE PATIENT VASCULATURE. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT AND REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE STENT WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY OR INTERVENTION, AND THERE WAS NO VESSEL DAMAGE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178327 ↗
• InjurySep 11, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE VISIPRO DURING PATIENT TREATMENT. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. A BALLOON BURST WAS REPORTED DURING PROCEDURE. A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED ON FIRST INFLATION AT 12ATMS. THE BALLOON DETACHED AND A SNARE WAS USED TO REMOVE THE DETACHED PIECES/FRAGMENTS OF THE BALLOON. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190496 ↗
• MalfunctionNov 16, 2022Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT 2 VISIPRO BALLOON EXPANDABLE STENTS WERE INTENDED TO BE IMPLANTED FOR THE TREATMENT OF A CALCIFIED LESION IN THE PROXIMAL REGION OF THE COMMON ILIAC ARTERY. THE ARTERY HAD SEVERE CALCIFICATION. A6 FR NON-MDT SHEATH WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE STENT DEFORMATION OCCURRED DURING POSITIONING/DEPLOYMENT AND THE STENT DISLODGED DURING REMOVAL OF THE STENT. THE PHYSICIAN USED A SNARE TO REMOVE THE DISLODGED STENT AFTER ADVANCING THE STENT THROUGH THE LESION WITHOUT PRE DILATING AND WITHOUT A SHEATH TO COVER THE LESION. THE DISLODGED STENT WAS SUCCESSFULLY REMOVED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS USED. A SECOND STENT WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED AFTER THE STENT WAS DEPLOYED THE PHYSICIAN WENT TO RE INFLATE THE BALLOON IN ANOTHER PART OF THE STENT AND THE BALLOON BURST, THEN WHEN TRYING TO REMOVE IT THE BALLOON BROKE AT THE DISTAL END. IT IS NOT KNOWN AT WHAT ATM THE BALLOON BURST. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804687 ↗
• MalfunctionJun 22, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A VISIO PRO BARE METAL STENT TO TREAT A LESION IN A PATIENT IN THE ILIAC ARTERY COMMON. DEVICE WAS PREPPED AS PER IFU. NO ISSUES NOTED WITH THE USE OF THE PRODUCT, HOWEVER, IT WAS NOTED THAT THE STENT WAS DEPLOYED APPROXIMATELY ONE MONTH POST EXPIRY, THE CASE WENT AS NORMAL, BUT THEY REALIZED AFTER THAT THE STENT WAS EXPIRED. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14774748 ↗