MaxForce™ M00567420Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729097099), received between Dec 3, 2018 and Dec 13, 2022 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, AFTER THE DILATION WAS COMPLETED, DEFLATION WAS ATTEMPTED TO BE PERFORMED; HOWEVER, THE BALLOON COULD NOT BE DEFLATED. THE PROCEDURE HAD ALREADY BEEN COMPLETED SUCCESSFULLY WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965961 ↗
• MalfunctionFeb 17, 2022Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY BALLOON WAS USED IN THE PAPILLA OF VATER DURING AN ENDOSCOPIC BALLOON DILATION (EBD) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WAS POORLY PRESSURIZED WHILE DILATING THE PAPILLA. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550093 ↗
• MalfunctionMay 10, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED DURING A DUODENAL PAPILLA DILATION PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE DEVICE WAS DIFFICULT TO MAINTAIN IN THE SCOPE AND THE BALLOON EVENTUALLY RUPTURED WHEN INFLATED TO LESS THAN 12 ATM. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802488 ↗
• MalfunctionJan 4, 2021Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATION BALLOON WAS USED IN THE BILE DUCT DURING A BILIARY TRACT DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS LEAKING NEAR THE BALLOON PROXIMAL SIDE WHEN INFLATED IN THE PAPILLA OF THE PATIENT, AND IT WAS DETERMINED THAT THE BALLOON RUPTURED. REPORTEDLY, THE BALLOON WAS TESTED PRIOR TO THE PROCEDURE WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11111871 ↗
• MalfunctionOct 12, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE DISTAL BILE DUCT DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE WHEN ATTEMPTED TO BE INFLATED. THE BALLOON WAS CHECKED AND SHOWED THAT THE BALLOON HAD A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666797 ↗
• MalfunctionFeb 12, 2020Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED DURING A ENDOSCOPIC PAPILLARY DILATION PROCEDURE PERFORMED IN THE BILE DUCT AND PAPILLA ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED; HOWEVER, THERE WAS SEVERE RESISTANCE AND DIFFICULTY IN INJECTING THE CONTRAST MEDIA INTO THE BALLOON. THE BALLOON WAS THEN DEFLATED, AND ANOTHER ATTEMPT WAS MADE TO INFLATE THE BALLOON IN THE PAPILLA. AFTER THE DILATION IT WAS NOTED THAT THE BALLOON COULD NOT BE DEFLATED. THE INFLATION DEVICE WAS DISCONNECTED FROM THE DEVICE, AND A SYRINGE WAS USED TO ATTEMPT TO DEFLATE THE BALLOON, BUT IT COULD STILL NOT BE DEFLATED. THE BALLOON WAS THEN REMOVED FROM THE PATIENT TOGETHER WITH THE ENDOSCOPE, AND THE BALLOON WAS PIERCED WITH A NEEDLE IN ORDER TO BE DEFLATED. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9701485 ↗
• MalfunctionOct 29, 2019Deflation Problem; Difficult to Remove; Deformation Due to Compressive Stress; Deflation Problem; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE DUODENUM NEAR THE PAPILLA AND COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE OF A PRODUCT DEVELOPMENT IN VIVO PORCINE ANIMAL LAB TRIAL ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, UPON WITHDRAWAL, IT WAS NOTICED THAT THE BALLOON WAS NOT DEFLATING WITH USE OF THE INFLATION DEVICE. REPORTEDLY, THE DEVICE WAS ATTEMPTED TO BE REMOVED PRIOR TO FULLY DEFLATING; HOWEVER, IT COULD NOT BE PULLED OUT OF THE SCOPE DUE TO THE BALLOON BUNCHING UP. IT WAS ALSO NOTED THAT THE GUIDEWIRE COULD NOT BE REMOVED DUE TO THE DAMAGE. THE DUODENUM WAS EXTUBATED FROM PORCINE MOUTH, AND THE DISTAL TIP OF THE DEVICE WAS CUT TO BE REMOVED FROM THE DUODENOSCOPE. THE PROCEDURE WAS COMPLETED AT THIS TIME. AS THIS OCCURRED DURING A PORCINE LAB, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9249169 ↗
• InjuryAug 7, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE COMMON HEPATIC DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, WHEN ATTEMPTING TO WITHDRAW THE CATHETER AFTER DEFLATION, THE BALLOON GOT STUCK IN THE STENOSIS. THIS RESULTED IN RUPTURE OF THE CATHETER. ATTEMPTS WERE MADE TO RETRIEVE THE BALLOON USING AN ADDITIONAL BALLOON AND A SPHINCTEROTOME, BUT WERE UNSUCCESSFUL. REPORTEDLY, CHOLEDOSCOPY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED AT THIS TIME. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 8868724 ↗
• MalfunctionJun 11, 2019Burst Container or Vessel; Burst Container or Vessel

  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 THE TWO MAXFORCE BILIARY DILATATION BALLOONS WERE USED IN THE PAPILLA DURING A BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AND UPON INFLATION, THE BALLOON RUPTURED BETWEEN 2ATM TO 3ATM. THE SAME ISSUE OCCURRED WITH THE SECOND MAXFORCE BILIARY DILATATION BALLOON, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687954 ↗
• MalfunctionJun 11, 2019Burst Container or Vessel; Burst Container or Vessel

  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 THE TWO MAXFORCE BILIARY DILATATION BALLOONS WERE USED IN THE PAPILLA DURING A BILE DUCT STONE REMOVAL PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AND UPON INFLATION, THE BALLOON RUPTURED BETWEEN 2ATM TO 3ATM. THE SAME ISSUE OCCURRED WITH THE SECOND MAXFORCE BILIARY DILATATION BALLOON, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8687047 ↗
• MalfunctionMay 28, 2019Material 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 A DILATION PROCEDURE PERFORMED ON (B)(6) 2019. IT WAS FOUND THAT THE BALLOON HAD A PINHOLE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8646614 ↗
• MalfunctionApr 18, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE BILE CHANNEL DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE BALLOON THROUGH THE DUODENOSCOPE AND THE BALLOON WAS ATTEMPTED TO BE INFLATED TO 8-10 ATM; HOWEVER, THE BALLOON BURST. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527798 ↗
• MalfunctionMar 21, 2019Material Puncture/Hole; Material Puncture/Hole

  ON (B)(6) 2019, BOSTON SCIENTIFIC CORPORATION RECEIVED AN UNAUTHORIZED RETURN OF A MAXFORCE BILIARY BALLOON. IT WAS FOUND THAT THE BALLOON HAD TWO PINHOLES. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8439917 ↗
• MalfunctionFeb 27, 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 IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC PAPILLARY BILIARY DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD A PINHOLE. THE SAME EVENT OCCURRED WITH THE SECOND DEVICE. THE PROCEDURE WAS NOT COMPLETED. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8373806 ↗
• MalfunctionFeb 27, 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 IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC PAPILLARY BILIARY DILATION (EPBD) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD A PINHOLE. THE SAME EVENT OCCURRED WITH THE SECOND DEVICE. THE PROCEDURE WAS NOT COMPLETED. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8373783 ↗
• MalfunctionDec 3, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE PAPILLA DURING AN ENDOSCOPICALLY PERFORMED BILIARY DRAINAGE (EPBD) PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS DIFFICULTY IN INFLATING THE BALLOON, AFTER ADDING PRESSURE THE BALLOON SUCCESSFULLY INFLATED; HOWEVER, IT CANNOT BE DEFLATED. REPORTEDLY, THE CATHETER WAS FORCIBLY REMOVED FROM THE PATIENT AND PAPILLOTOMY WAS ADDITIONALLY PERFORMED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8126327 ↗