Passport M0062181000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729154921), received between Jun 11, 2019 and Feb 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED IN THE KIDNEY DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, PHYSICIAN TRIED TO PLACE THE BALLOON ON THE GUIDEWIRE; HOWEVER, THE TIP OF THE BALLOON GOT BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548714 ↗
• MalfunctionJun 11, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST DURING INFLATION. REPORTEDLY, THE TRANSPARENT BALLOON PORTION OF THE DEVICE THAT DETACHED WAS NOT RETRIEVED, THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATION CATHETER. THERE WRERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8686487 ↗