Occluder M0062201100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729161691), received between Jun 5, 2017 and Nov 2, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE URETER DURING A PERCUTANEOUS NEPHROLITHONOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE OCCLUDER BALLOON WAS INSERTED IN THE KIDNEY; HOWEVER, WHEN THEY WENT TO INFLATE THE BALLOON, THERE WAS NO EFFECT. THEY TRIED TO INFLATE AGAIN BUT STILL THE BALLOON DID NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON WAS RUPTURED. PLEASE SEE DEVICE ANALYSIS RESULTS FOR FULL INVESTIGATION DETAILS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18060565 ↗
• MalfunctionJun 22, 2021Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE TO BE USED IN THE URETER/KIDNEY PERFORMED ON (B)(6) 2021. DURING PREPARATION, THE BALLOON WAS NOTED TO BE LEAKING WHILE THE CONTRAST WITH NACL WAS BEING INSERTED WITHOUT INFLATING THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUDER BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THIS BALLOON HAS A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12045715 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER BALLOON CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY WITH PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AND PLACED IN A TIGHT URETEROPELVIC JUNCTION (UPJ) STRICTURE IN WHICH CAUSED A SMALL TEAR IN THE URETER OF THE PATIENT. REPORTEDLY, A STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WAS NO ALLEGED MALFUNCTION OR DEFICIENCY OF THE OCCLUDER BALLOON CATHETER. IN THE PHYSICIAN'S ASSESSMENT, THE BALLOON BEING PLACED IN A TIGHT STRICTURE COULD HAVE CAUSED THE STRICTURE TO STRETCHED RESULTING TO A TEAR IN THE URETER OF THE PATIENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: Laceration(s)

  MAUDE report 11663759 ↗
• MalfunctionJul 9, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUSION BALLOON CATHETER WAS USED IN THE URETER DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BURST UPON INFLATION. REPORTEDLY, THE PHYSICIAN FELT THAT THE BALLOON WAS PUSHED INTO A SHARP STONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OCCLUSION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771014 ↗
• InjuryJun 5, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OCCLUDER OCCLUSION BALLOON CATHETER WAS USED DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON CAME APART AND HAD TO BE RETRIEVED INSIDE PATIENT, THOUGH IT IS UNKNOWN HOW IT WAS RETRIEVED. AT THE CONCLUSION OF THE PROCEDURE THERE WAS REPORTED TO BE NO HARM TO THE PATIENT. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6613153 ↗