Visi-Pro™ PXB35-05-17-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169787582), received between Oct 31, 2019 and Mar 27, 2025 — classified as 3 injuries, 1 malfunction.

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 18, 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.

• InjuryMar 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE USE OF THE VISIPRO STENT, THE STENT DISLODGED AND WAS DEPLOYED DISTAL TO THE LESION IN THE PROXIMAL REGION OF THE RIGHT RENAL ARTERY, WHICH WAS DESCRIBED AS HAVING MODERATE CALCIFICATION AND TORTUOSITY. THE ARTERY DIAMETER WAS 5 MM. A 6FR NON-MEDTRONIC SHEATH AND 035 GUIDEWIRE WAS USED. THERE WAS NO RESISTANCE WHEN ADVANCING THE DEVICE. THE VESSEL WAS NOT THE ISSUE LED TO THE PATIENT'S CREATININE LEVELS AND BLOOD PRESSURE RISING, AND KIDNEY FUNCTION/URINE OUTPUT IS DECREASING. ATTEMPTS TO SNARE THE DISLODGED STENT WERE UNSUCCESSFUL. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED FOR EVALUATION BY A TRANSPLANT TEAM. NO DEFORMATION NOTED TO THE DEPLOYED STENT. THE PROCEDURE WAS COMPLETED USING A NEW VISIPRO. THE STENT REMAINED IN THE PATIENT, AND THE BALLOON CATHETER WAS REMOVED. THE VESSEL WAS POST DILATED WITH A 6 X 40 MM NON-MEDTRONIC DEVICE. THE ISSUE IS STILL PRESENT.

  Patient problems: High Blood Pressure/ Hypertension; Renal Impairment

  MAUDE report 21709393 ↗
• InjuryJan 7, 2025Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WERE INFLATION DIFFICULTIES WITH A VISI PRO BALLOON EXPANDABLE STENT 035 DURING A PROCEDURE. NO ISSUES NOTED NOTED TO THE PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM ITS TRAY. IFU WAS FOLLOWED. EMBOLIC PROTECTION WAS NOT USED. IT IS UNKNOWN IF THE VESSEL WAS PRE/POST DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS UNKNOW IF RESISTANCE WAS ENCOUNTERED. THE STENT WAS LOCATED IN THE MID-SECTION OF AN ARTERY OR VEIN (SMA). IT IS NOT KNOWN WHAT PRESSURE ISSUE OCCURED AND THERE WERE NO LEAKS REPORTED. SURGICAL INTERVENTION WAS REQUIRED (OPEN CASE) TO REMOVE THE STENT, PHYSICIAN REPORTED THAT DURING DEPLOYMENT/PLACEMENT THE STENT BECAME STUCK AND DISLODGED FROM THE DELIVERY CATHETER. ARTERY BALLOONED SEVERAL TIMES, A GUIDEWIRE WAS SUCCESSFULLY ABLE TO GET THROUGH THE ARTERY AND THE STENT WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090027 ↗
• InjuryMay 26, 2021Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO BALLOON EXPANDABLE STENT TO TREAT A LESION IN THE PROX RENAL ARTERY IN A PATIENT. IFU WAS FOLLOWED WITH NO ISSUES NOTED. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED - THE STENT WOULDN¿T CROSS THE LESION AND UPON REMOVAL FROM THE SHEATH THE STENT POPPED OFF THE BALLOON AT THE VALVE. THE STENT WAS NOT ELONGATED OR SHORTENED IN THE PATIENT. A SNARE WAS USED FOR RETRIEVAL OF THE STENT. THE DEVICE WAS SAFELY REMOVED. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11886986 ↗
• MalfunctionOct 31, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PHYSICIAN USED A VISIPRO BALLOON EXPANDABLE STENT WITH A NON-MEDTRONIC 6FR SHEATH AND 0.035, 260CM NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 14MM FIBROUS LESION IN THE PATIENT¿S PROXIMAL BILIARY ARTERY OF DIAMETER 5MM. LESION EXHIBITED 90% STENOSIS. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. NO DAMAGED NOTED TO PACKAGE PRIOR TO USE NOR ISSUES NOTED WHEN REMOVING FROM PACKAGING. PRE-DILATION WAS PERFORMED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT THE STENT DISLODGED DISTAL TO THE TARGET LESION IN THE DISTAL INFERIOR MESENTERIC ARTERY (IMA). NO ATTEMPTS WERE MADETO REMOVE THE DISLODGED STENT. A NON-MEDTRONIC BALLOON EXPANDABLE COVERED STENT WAS THEN DEPLOYED AT THE TARGET LESION. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9259786 ↗