MaxForce TTS M00589180Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729099925), received between Mar 13, 2019 and Feb 15, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 15, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE TTS DILATATION BALLOON WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WAS SET UP PROPERLY, BUT ONCE INFLATED IN THE PATIENT TO DILATE, THE BALLOON BURST AT 18 MM WITH NO HARM TO THE PATIENT. THE CUSTOMER STATED THAT NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712975 ↗
• MalfunctionNov 29, 2021Material Puncture/Hole; Material Puncture/Hole

  KIT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT MAXFORCE TTS DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN UPPER ENDOSCOPE PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PROCEDURE, IT WAS NOTICED THAT THE A HOLE IN THE BALLOON AND COULD ONLY FILL HALF WAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE TTS DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885306 ↗
• MalfunctionApr 5, 2021Material Puncture/Hole; Defective Device; Material Puncture/Hole; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE TTS DILATATION BALLOON WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. INVESTIGATION RESULTS REVEALED THAT THE BALLOON HAD A PINHOLE; THEREFORE, THIS IS NOW AN MDR REPORTABLE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11616191 ↗
• MalfunctionSep 9, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE TTS DILATATION BALLOON WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. 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 10511112 ↗
• MalfunctionDec 9, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE TTS DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON NOVEMBER (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON POPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE TTS 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 9439449 ↗
• MalfunctionJun 11, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE TTS DILATATION BALLOON WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AND UPON DILATION, THE BALLOON POPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE TTS 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8688618 ↗
• MalfunctionMay 6, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE TTS DILATATION BALLOON WAS USED IN THE ESOPHAGUS AND UPPER PART OF THE STOMACH DURING AN ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS BENT FORTY FIVE PERCENT AT THE BASE OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE TTS 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 8583241 ↗
• MalfunctionMar 13, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE TTS DILATATION BALLOON WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BROKE WHILE INSIDE THE PATIENT. 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 OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417546 ↗