MaxForceRecalls & reported problems across all models
Boston Scientific Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 91
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 6 models of MaxForce by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 91 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2018 and Mar 30, 2023 — classified as 1 injury, 90 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (57 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 MaxForce problems
Device problems
- Material Puncture/Hole57
- Burst Container or Vessel28
- Obstruction of Flow6
- Material Deformation4
- Deflation Problem3
- Inflation Problem3
- Detachment of Device or Device Component2
- Difficult to Remove2
Patient problems
- No Consequences Or Impact To Patient76
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient4
- Insufficient Information2
- No Code Available1
- No Patient Involvement1
MaxForce models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MaxForce™ M00567340CATHETER, BILIARY, DIAGNOSTIC39 reports
- MaxForce™ M00567380CATHETER, BILIARY, DIAGNOSTIC19 reports
- MaxForce™ M00567420CATHETER, BILIARY, DIAGNOSTIC16 reports
- MaxForce™ M00567330CATHETER, BILIARY, DIAGNOSTIC9 reports
- MaxForce™ M00567370CATHETER, BILIARY, DIAGNOSTIC6 reports
- MaxForce™ M00567410CATHETER, BILIARY, DIAGNOSTIC2 reports
Recent MaxForce adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2023Material Puncture/Hole
WHILE TRYING TO DILATE THE PANCREATIC DUCT WITH MAXFORCE BILIARY 4MM X 4CM BALLOON DILATION CATHETER WAS NOTED THE BALLOON HAD A HOLE.
Patient problems: Insufficient Information
MAUDE report 16642960 ↗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 ↗MalfunctionJul 6, 2021Entrapment of Device; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Entrapment of Device; Detachment of Device or Device Component; Difficult to Advance; Material Deformation
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), 2021. DURING THE PROCEDURE, THE DEVICE WAS ADVANCE OVER THE GUIDEWIRE; HOWEVER, THE DEVICE COULD NOT ADVANCE FARTHER THAN 30 CM. SUBSEQUENTLY, THE CATHETER BUNCHED UP IN ACCORDION AND THE GUIDEWIRE COULD NOT BE REMOVED EITHER. THE DEVICE WAS THEN SUCCESSFULLY REMOVED FROM THE SCOPE USING FORCE WHICH RIPPED OFF THE BALLOON. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 12125866 ↗MalfunctionJul 1, 2021Material Puncture/Hole; Material Puncture/Hole
BOSTON SCIENTIFIC CORPORATION RECEIVED A MAXFORCE BILIARY DILATION BALLOON DEVICE WITH NO ASSOCIATED INFORMATION. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS OF BALLOON PINHOLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: Insufficient Information
MAUDE report 12099645 ↗MalfunctionJun 1, 2021Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL PART OF THE BALLOON WAS LEAKING DUE TO A PINHOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATATION BALLOON OF A DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11912938 ↗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 ↗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 ↗MalfunctionFeb 15, 2021Material 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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE AND WAS LEAKING. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE BILE DUCT TO INSPECT ENDOSCOPICALLY, AND IT WAS FOUND THAT THE BALLOON HAD AT LEAST 3 SMALL HOLE LEAKS. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 11327901 ↗MalfunctionFeb 10, 2021Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED 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 Clinical Signs, Symptoms or Conditions
MAUDE report 11306888 ↗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 ↗MalfunctionDec 16, 2020Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; 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 PREPARATION, THE BALLOON WAS INFLATED OUTSIDE THE PATIENT FOR TESTING; HOWEVER, THE BALLOON WOULD NOT INFLATE DUE TO 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11021719 ↗MalfunctionDec 3, 2020Burst Container or Vessel; Burst Container or Vessel
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) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10941383 ↗MalfunctionNov 9, 2020Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATION BALLOON WAS USED IN A DILATATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE BALLOON BURST WHEN INFLATED OUTSIDE THE PATIENT. 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 Consequences Or Impact To Patient
MAUDE report 10812787 ↗MalfunctionNov 5, 2020Material Puncture/Hole; Material Puncture/Hole
BOSTON SCIENTIFIC CORPORATION RECEIVED AN UNAUTHORIZED RETURN OF A MAXFORCE BILIARY DILATATION BALLOON. IT WAS FOUND THAT THE BALLOON HAD A PINHOLE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10791367 ↗
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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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