Passport M0062181110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729154969), received between Oct 3, 2017 and Dec 20, 2017 — classified as 2 malfunctions.

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

• MalfunctionDec 20, 2017Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.  INVESTIGATION RESULTS REVEALED THERE WERE MULTIPLE KINKS ON THE DISTAL RADIOPAQUE SHAFT, THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133214 ↗
• MalfunctionOct 3, 2017Deflation Problem; Deflation Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2017-03004 PERTAINS TO THE FIRST PASSPORT BALLOON DILATATION CATHETER, MANUFACTURER REPORT # 3005099803-2017-03005 PERTAINS TO THE SECOND PASSPORT BALLOON DILATATION CATHETER AND MANUFACTURER REPORT # 3005099803-2017-03006 PERTAINS TO THE THIRD PASSPORT BALLOON DILATATION CATHETER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE PASSPORT BALLOON DILATATION CATHETERS WERE USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOONS WOULD NOT DEFLATE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6910180 ↗