PassportRecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of Passport by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2017 and Feb 17, 2022 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Passport problems
Device problems
- Burst Container or Vessel12
- Deflation Problem3
- Material Puncture/Hole3
- Material Twisted/Bent2
- Inflation Problem1
- Kinked1
Patient problems
- No Consequences Or Impact To Patient15
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient1
Passport models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Passport M0062181100DILATOR, CATHETER, URETERAL15 reports
- Passport M0062181000DILATOR, CATHETER, URETERAL2 reports
- Passport M0062181110DILATOR, CATHETER, URETERAL2 reports
- Passport M0062181010DILATOR, CATHETER, URETERAL1 report
Recent Passport adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJan 14, 2022Material Puncture/Hole; Material Twisted/Bent; Material Puncture/Hole; Material Twisted/Bent
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON HAD A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE PHOTOS SUBMITTED BY THE CUSTOMER SHOWS THE BALLOON OUTSIDE THE PATIENT AND IT WAS OBSERVED THAT THE DISTAL TIP OF THE CATHETER WAS KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13259232 ↗MalfunctionDec 8, 2021Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE CONTRAST AGENT CONTINUED TO DRAIN OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. NOTE: A PHOTO WAS SUBMITTED BY THE CUSTOMER SHOWING A DEFLATED BALLOON. NO VISIBLE PROBLEM WAS NOTED TO THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12962237 ↗MalfunctionJun 11, 2021Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS NOT INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11981939 ↗MalfunctionDec 14, 2020Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATATION CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ATTEMPTING TO INFLATE THE BALLOON TO 7 ATM, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11002319 ↗MalfunctionMay 21, 2020Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT DILATATION BALLOON CATHETER DEVICE WAS USED IN THE LEFT URETER DURING A UTEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST UNDER 8.5 ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10078399 ↗MalfunctionApr 10, 2020Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A PASSPORT DILATION BALLOON CATHETER DEVICE WAS USED IN THE LEFT URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON INFLATED UNDER 8ATM; HOWEVER, IT EXPLODED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT DILATION BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9947758 ↗MalfunctionJan 23, 2020Burst Container or Vessel; Burst Container or Vessel
NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO PASSPORT DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO PASSPORT DILATATION BALLOON DEVICES WERE USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH OF THE BALLOON BURST. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9623563 ↗MalfunctionJun 20, 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 RIGHT URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8716228 ↗MalfunctionJun 20, 2019Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT DILATATION BALLOON WAS USED IN THE URETER DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8716210 ↗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 ↗MalfunctionMay 21, 2019Burst Container or Vessel; Burst Container or Vessel
NOTE: THIS REPORT PERTAINS TO ONE OF TWO PASSPORT BALLOON DILATATION CATHETERS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO PASSPORT BALLOON DILATATION CATHETER DEVICES WERE USED IN THE URETER DUING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE SAME ISSUE OCCURED ON THE SECOND PASSPORT BALLOON DILATATION CATHETER. 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 Consequences Or Impact To Patient
MAUDE report 8627571 ↗MalfunctionMay 21, 2019Burst Container or Vessel; Burst Container or Vessel
NOTE: THIS REPORT PERTAINS TO ONE OF TWO PASSPORT BALLOON DILATATION CATHETERS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO PASSPORT BALLOON DILATATION CATHETER DEVICES WERE USED IN THE URETER DUING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST. THE SAME ISSUE OCCURED ON THE SECOND PASSPORT BALLOON DILATATION CATHETER. 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 Consequences Or Impact To Patient
MAUDE report 8627570 ↗MalfunctionMar 26, 2019Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT DILATATION BALLOON CATHETER WAS USED IN THE LEFT URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT DILATATION BALLOON CATHETER . THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8453012 ↗MalfunctionJan 8, 2019Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PASSPORT BALLOON DILATION CATHETER WAS USED IN THE UPPER URETER DURING AN UPPER URS PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST INSIDE THE PATIENT. REPORTEDLY, THE TRANSPARENT BALLOON PORTION OF THE DEVICE THAT DETACHED WAS NOT RETRIEVED AND WAS LEFT TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER PASSPORT BALLOON DILATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8228815 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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