MaxForce™ M00567370Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729097068), received between Dec 24, 2019 and Jul 1, 2021 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 24, 2019Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATION BALLOONS WERE USED IN THE BILE DUCT DURING A BILE DUCT DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE. THE SAME ISSUE "OCURRED" IN THE SECOND MAXFORCE BILIARY DILATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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. 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 9516362 ↗
• MalfunctionDec 24, 2019Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY DILATION BALLOONS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATION BALLOONS WERE USED IN THE BILE DUCT DURING A BILE DUCT DILATION PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE. THE SAME ISSUE "OCURRED" IN THE SECOND MAXFORCE BILIARY DILATION BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD TWO PINHOLES; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516352 ↗
• MalfunctionDec 24, 2019Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATION BALLOONS WERE USED DURING A BILIARY DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, BOTH BALLOONS WOULD NOT INFLATE DUE TO SMALL HOLES. REPORTEDLY, THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATION 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 9516301 ↗
• MalfunctionDec 24, 2019Material Puncture/Hole; Material Puncture/Hole

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO MAXFORCE BILIARY BALLOONS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO MAXFORCE BILIARY DILATION BALLOONS WERE USED DURING A BILIARY DILATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, BOTH BALLOONS WOULD NOT INFLATE DUE TO SMALL HOLES. REPORTEDLY, THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY DILATION 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 9516281 ↗
• MalfunctionDec 24, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY DILATATION BALLOON WAS USED IN THE HEPATIC PORTAL DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD A PINHOLE-LIKE HOLE. 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 9515931 ↗