MaxForce™ M00567330Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729097037), received between Mar 21, 2019 and Feb 24, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON; HOWEVER, RESISTANCE WAS FELT INDICATING THE BALLOON WAS INFLATING AND THEN THE PRESSURE GAUGE ZEROED OUT. THE BALLOON WAS PULLED OUT AND IT WAS NOTICED THAT IT POPPED CAUSING THE DEVICE TO LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372002 ↗
• MalfunctionOct 26, 2020Material Puncture/Hole; Obstruction of Flow; Material Puncture/Hole; Obstruction of Flow

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE MAXFORCE BILIARY DILATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE MAXFORCE BILIARY DILATION BALLOONS WERE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON WAS LEAKING AND A HOLE WAS DETECTED. THE SAME ISSUE OCCURRED WITH THE SECOND AND THIRD MAXFORCE BILIARY DILATION BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THIS BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10735795 ↗
• MalfunctionOct 26, 2020Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE MAXFORCE BILIARY DILATION BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE MAXFORCE BILIARY DILATION BALLOONS WERE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT WAS NOTICED THAT THE BALLOON WAS LEAKING AND A HOLE WAS DETECTED. THE SAME ISSUE OCCURRED WITH THE SECOND AND THIRD MAXFORCE BILIARY DILATION BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THIS BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10734688 ↗
• MalfunctionMar 16, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, IT DID NOT INFLATE. REPORTEDLY, THE BALLOON WAS THEN REMOVED FROM THE PATIENT AND WAS CHECKED. A HOLE WAS NOTICED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. 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 Consequences Or Impact To Patient

  MAUDE report 9836538 ↗
• MalfunctionNov 27, 2019Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO MAXFORCE BILIARY DILATATION BALLOON USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOON DEVICES WERE USED IN THE BILE DUCT DURING A BILIARY DILATATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS PRE-INFLATED AND IT WAS NOTICED THAT THE BALLOON HAD SMALL HOLES. THE SAME EVENT OCCURRED WITH THE SECOND DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9386440 ↗
• MalfunctionNov 27, 2019Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO MAXFORCE BILIARY DILATATION BALLOON USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOON DEVICES WERE USED IN THE BILE DUCT DURING A BILIARY DILATATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE BALLOON WAS PRE-INFLATED AND IT WAS NOTICED THAT THE BALLOON HAD SMALL HOLES. THE SAME EVENT OCCURRED WITH THE SECOND DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9386418 ↗
• MalfunctionSep 30, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS AN ATTEMPT TO INFLATE THE BALLOON; HOWEVER, THE BALLOON WAS UNABLE TO BE INFLATED. REPORTEDLY, THE BALLOON WAS REMOVED FROM THE PATIENT AND NOTED THAT THERE WAS A HOLE ON THE BALLOON. THE PROCEDURE WAS COMPLETED AT THIS TIME. 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 STABLE. INVESTIGATION RESULTS REVEALED THAT THE BALLOON FOUND A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9136316 ↗
• MalfunctionMar 21, 2019Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOON WERE USED DURING A BILIARY DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD SMALL HOLES. THE SAME EVENT OCCURRED WITH THE SECOND DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8440133 ↗
• MalfunctionMar 21, 2019Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATATION BALLOON WERE USED DURING A BILIARY DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD SMALL HOLES. THE SAME EVENT OCCURRED WITH THE SECOND DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8440129 ↗