Alliance II M00550620Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729283881), received between Nov 5, 2020 and Oct 5, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE HANDLE INFLATION DEVICE WAS BEING PREPARED FOR USE IN AN ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE INFLATION DEVICE WAS UNABLE TO INFLATE THE BALLOON. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881880 ↗
• MalfunctionSep 12, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ALLIANCE II INFLATION/LITHO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ALLIANCE II INFLATION/LITHO DEVICES WERE USED DURING A DILATATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PRESSURE DOES NOT GO UP WHEN THE PRESSURE IS INCREASED BUT GOES DOWN IMMEDIATELY. THE SAME PROBLEM OCCURRED WITH THE SECOND ALLIANCE II INFLATION/LITHO DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION/LITHO DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733638 ↗
• MalfunctionSep 12, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO ALLIANCE II INFLATION/LITHO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ALLIANCE II INFLATION/LITHO DEVICES WERE USED DURING A DILATATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE PRESSURE DOES NOT GO UP WHEN THE PRESSURE IS INCREASED BUT GOES DOWN IMMEDIATELY. THE SAME PROBLEM OCCURRED WITH THE SECOND ALLIANCE II INFLATION/LITHO DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALLIANCE II INFLATION/LITHO DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733637 ↗
• MalfunctionNov 29, 2021Inflation Problem; Appropriate Device Problem Term/Code Not Available; Inflation Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE HANDLE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE GALLBLADDER ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE HANDLE LEVER FAILED TO PROVIDE PRESSURE TO THE DEVICE. ADDITIONALLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, AND THE REPLANNED PROCEDURE HAS BEEN COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882973 ↗
• MalfunctionNov 8, 2021Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE HANDLE WAS USED DURING A SPHINCTEROPLASTY PROCEDURE PERFORMED IN THE COMMON BILE DUCT (CBD) ON (B)(6) 2021. DURING THE PROCEDURE, WHILE INFLATING THE CRE BALLOON IT WAS NOTICED THAT THERE WAS A SLIGHT RESISTANCE IN THE HANDLE. THE SPRING CAME OUT OF THE HANDLE. THE PROCEDURE WAS NOT COMPLETED AND THE PATIENT WAS SENT TO A DIFFERENT HOSPITAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771189 ↗
• MalfunctionJul 29, 2021Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT REFERS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE HANDLE WAS USED DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE HANDLE WAS FAULTY. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS ANOTHER SPARE HANDLE WAS ALSO FAULTY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246339 ↗
• MalfunctionJul 29, 2021Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT REFERS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE HANDLE WAS USED DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE HANDLE WAS FAULTY. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS ANOTHER SPARE HANDLE WAS ALSO FAULTY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12246333 ↗
• MalfunctionNov 5, 2020Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ALLIANCE HANDLE WAS UNPACKED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE METAL SEATBELT ON THE SIDE OF THE DEVICE THAT HOLDS THE SYRINGE IN PLACE BROKE OFF. REPORTEDLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, AND THE PROCEDURE WAS RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10793517 ↗