Visi-Pro™ PXB35-06-27-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169787698), received between Apr 25, 2019 and Oct 6, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryOct 6, 2023Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem

  PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A 7X10CM NON-MEDTRONIC SHEATH AND A 0.035/260CM NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S LEFT PROXIMAL RENAL ARTERY. NO VESSEL TORTUOSITY REPORTED. THE LESION WAS MODERATE TO HEAVY CALCIFIED LEFT RENAL ARTERY, DISEASED AT PROXIMAL VESSEL AND FAIRLY STRAIGHT SEGMENT. 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 DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED ON (B)(6) 2023, DURING AN ABDOMINAL ANGIOGRAM WITH PLANNED RENAL ARTERY STENT PLACEMENT, THE VISIPRO STENT WAS UNABLE TO CROSS THE LESION. DURING ATTEMPT TO REMOVE STENT FROM THE BODY, THE BALLOON-MOUNTED VISIPRO STENT SLIPPED OFF THE DELIVERY SYSTEM. AFTER REMOVING DELIVERY SYSTEM FROM THE BODY, THE PHYSICIAN ATTEMPTED TO USE A 7FR 27-45MM NON-MEDTRONIC SNARE TO RETRIEVE STENT BUT IT WAS UNSUCCESSFUL. THE SNARED STENT WAS TOO BIG TO REMOVE THROUGH THE SHEATH AND THE ACCESS WAS LOST IN ORDER TO REMOVE THE STENT. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885339 ↗
• InjuryFeb 23, 2021Fracture; Fracture

  PHYSICIAN IMPLANTED A VISIPRO BALLOON EXPANDABLE STENT DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE MID BILIARY ARTERY OF SUPERIOR MESENTERIC ARTERY (SMA) WITH 90+% STENOSIS. THE VESSEL WAS MODERATELY CALCIFIED. THE VESSEL DIAMETER AND LESION LENGTH WERE 6MM AND 30MM RESPECTIVELY. NON-MEDTRONIC 6FR SHEATH AND 0.035" GUIDEWIRE WERE USED DURING PROCEDURE. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. POST ANGIOGRAPHY REVEALED BRISK FLOW WITH THE STENT FULLY INFLATED. POST PROCEDURE, THERE WAS NO IDENTIFIED ISSUES WITH THE VISIPRO. WHEN THE PATIENT WAS SEEN FOR A FOLLOW UP APPOINTMENT, THE VISIPRO STENT FRACTURE WAS NOTED ON THE MRI. THERE WAS NO VESSEL DAMAGE NOTED. THERE WAS NO OTHER STENT PRESENT IN THE SMA BESIDES THE VISIPRO. THE STENT WAS NOT REMOVED AND A NON-MEDTRONIC STENT WAS PLACED. PATIENT IS DOING WELL AND SEEN AT FOLLOW-UP. IMAGING SHOWS STENT FRACTURED IN HALF. THERE ARE NO PL

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11363951 ↗
• MalfunctionOct 29, 2019Entrapment of Device; Fracture; Migration or Expulsion of Device; Entrapment of Device; Fracture; Migration or Expulsion of Device

  PHYSICIAN USED A VISIPRO STENT WITH A 6FR X 70CM NON-MEDTRONIC SHEATH AND 0.035 X 260CM NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 23MM LESION IN THE PATIENT¿S PROXIMAL SUPERIOR MESENTERIC ARTERY (SMA) OF DIAMETER 6MM. IFU WAS FOLLOWED. THE DEVICE WAS PREPPED WITHOUT ISSUE. THE LESION WAS PRE-DILATED USING A NON-MEDTRONIC 6.0MM X 20MM BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE AND THE STENT PLACED SUCCESSFULLY. PATIENT FOLLOW-UP SCAN CARRIED OUT 3 DAYS POST PROCEDURE SHOWED THE STENT WAS BROKEN IN HALF AND TRAPPED ON STENT PLACED IN THE INFERIOR MESENTERIC ARTERY (IMA). NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9249207 ↗
• InjuryApr 25, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A VISIPRO STENT TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE MID RIGHT COMMON ILIAC ARTERY. THE LESION WAS NOT PRE-DILATED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH AND A 0.035¿ NON-MEDTRONIC GLIDE WIRE WERE USED FOR THE PROCEDURE. THERE WAS NO EMBOLIC PROTECTION USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT HOWEVER, RESISTANCE WAS ENCOUNTERED BUT NO EXCESSIVE FORCE WAS APPLIED DURING ADVANCEMENT OF THE DEVICE TO THE LESION. IT WAS REPORTED THAT AS THE STENT WAS BEING DELIVERED TO THE TARGET LESION, IT BECAME STUCK ON AN AREA OF CALCIUM. WHEN THE PHYSICIAN PULLED BACK TO REPOSITION THE STENT, IT DISLODGED AT THE LESION. 2 EVERCROSS BALLOONS -A 3X40, A 6X40 ¿ WERE USED TO FULLY DEPLOY THE STENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8548814 ↗