UltraPulse® DUO UltraPulse DUORecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 07290109140322), received between Apr 18, 2019 and Sep 22, 2026 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Failure to Align; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862456 ↗
• MalfunctionSep 18, 2026Failure to Align

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828347 ↗
• MalfunctionSep 15, 2026Nonstandard Device; Failure to Align

  It was reported that during preventive maintenance, it was noticed that the laser was out of alignment and the arm holder clip broke off. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769829 ↗
• MalfunctionAug 12, 2026Nonstandard Device; Failure to Align

  It was reported that laser is not firing. No further details were provided. Further information received stated that the aiming beam and treatment beam were misaligned, the Field service engineer found that that the laser does fire the treatment beam, but is not aligned with the aiming beam out of the arm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225952 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE A PATIENT EXPERIENCED BURN INJURY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Burn(s)

  MAUDE report 25788498 ↗
• MalfunctionMay 11, 2026Nonstandard Device; Failure to Align; Optical Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE AIMING BEAM WAS FADED. ADDITIONALLY, THE ALIGNMENT ON THE ARM IS WAY OFF AND NEEDS ALIGNMENT AND CALIBRATIONS. FURTHER INVESTIGATION INDICATED THAT NO PHYSICAL ISSUES WERE OBSERVED; HOWEVER, THE DEVICE WAS NOT FUNCTIONING AS INTENDED, INCLUDING FAILURE TO RECORD, INABILITY TO TOGGLE BETWEEN MODES, LACK OF ACTIVATION OR RESPONSE, AND NOTICEABLE LIGHT DIMMING. NO INFORMATION REGARDING THE PATIENT OR PROCEDURE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137895 ↗
• MalfunctionApr 29, 2026Failure to Align; Failure to Fire

  IT WAS REPORTED THAT DURING PREPARATION, THE AIMING BEAM WAS MISALIGNED, AS THE RED DOT WAS NOT PROPERLY ALIGNED WITHIN THE TARGETING CIRCLE. THE RANGE IN THE MICROSCOPE WHEN USING THE MICROMANIPULATOR WAS NOT FULL RANGE. ADDITIONALLY, THE MICROMANIPULATORS ADJUSTMENT KNOB WAS LOOSE AND SLIDING. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038122 ↗
• MalfunctionApr 6, 2026Failure to Align; Failure to Fire

  IT WAS REPORTED THAT THE CONSOLE PRESENTED ALIGNMENT PROBLEMS, AS THE AIMING BEAM WAS NOT CENTERED THROUGH THE ARTICULATED ARM. THERE WERE NO PROCEDURE AND PATIENT OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793348 ↗
• MalfunctionMar 31, 2026Nonstandard Device; Failure to Align

  IT WAS REPORTED THAT DURING TESTING, THE CONSOLE DISPLAYED THAT NEEDS AN ALIGNMENT. IT WAS NOTICED THAT THE AIMING BEAM OUTPUT FROM ARM WAS HITTING THE SIDE OF THE ARM AND IS OUT OF ALIGNMENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747688 ↗
• MalfunctionMar 19, 2026Optical Problem; Output below Specifications

  IT WAS REPORTED THAT THIS UNIT HAD PROBLEMS WITH AIMING BEAM AND POWER WAS LOW. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644335 ↗
• MalfunctionMar 12, 2026Failure to Align

  IT WAS REPORTED THAT THERE IS AN ALIGNMENT ANOMALY. NO ERRORS WERE OBSERVED. IT MAY BE RELATED TO THE AIMING BEAM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580034 ↗
• MalfunctionMar 5, 2026Failure to Align

  IT WAS REPORTED THAT, THE CONSOLE ARM IS MISALIGNED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24527449 ↗
• MalfunctionSep 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PROCEDURE, THE CONSOLE ARM WAS OUT OF ALIGNMENT. THE PROCEDURE WAS COMPLETED WITH ORIGINAL DEVICE WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151147 ↗
• MalfunctionJun 23, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE CONSOLE LOST POWER BUT STILL MAKING SOUND AS IF IT WAS LASING. THE ESTOP WAS PRESSED AND THE LASER RESTARTED, BUT THE CONSOLE KEPT FREEZE. THE CONSOLE SCREEN WAS FROZEN AND COULD NOT BE PLACED ON STANDBY, THE CASE WAS ABORTED, HOWEVER MOST OF THE PROCEDURE WAS COMPLETED. THE PATIENT WAS UNDER GENERAL ANESTHESIA, HOWEVER, THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE ENDED EARLIER, BUT THE PHYSICIAN WAS SATISFIED WITH THE RESULTS AND THE PATIENT NEEDED TO BE TREATED AGAIN. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308430 ↗
• MalfunctionJun 17, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE CONSOLE IS NOT WORKING AS EXPECTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233339 ↗
• MalfunctionMay 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT CONSOLE SHOWED MISALIGNMENT BETWEEN AIMING BEAM AND WORKING LASER BEAM. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING PROCEDURE OR PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079146 ↗
• MalfunctionApr 9, 2025Defective Device; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Defective Device; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE ARTICULATED ARM AIMING BEAM WAS OUT OF ALIGNMENT. IN ADDITION, CABLE PLASTIC CLIPS ARE MISSING AND THE ANTENNA IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21810644 ↗
• MalfunctionApr 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING INSTALLATION OF AN ACCESSORY TO THE CONSOLE, WAS FOUND THAT THE ARTICULATING ARM ALIGNMENT WAS OFF AND WAS "WALKING" AS THEY MOVED IT AROUND. THE AIMING WAS OFF TOO AT CERTAIN ANGLES. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741729 ↗
• MalfunctionMar 28, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE SYSTEM IS MISALIGNED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718889 ↗
• MalfunctionMar 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE BEAM OUT OF THE ARM IS MISALIGNED AND WEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641995 ↗
• MalfunctionMar 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT LASER AIMING BEAM IS OFF CENTER, CREATING A HALO EFFECT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OR PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529567 ↗
• MalfunctionJan 23, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT, THE CONSOLE MIGHT HAVE A SPLIT/DOUBLE LASER BEAM. IT ALSO DOES NOT SEEM LIKE THE CONSOLE IS AT FULL POWER. NO ERROR CODES WERE REPORTED. THERE IS NO PATIENT AND PROCEDURE OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223749 ↗
• MalfunctionJan 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE THE AIMING BEAM WAS STUCK TO THE RIGHT AND WOULD NOT CENTER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144163 ↗
• MalfunctionDec 3, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT IN MIDDLE OF THE CASE, THE LASER CONSOLE DISPLAYED ERROR CODE 35. THE DEVICE WAS RESTARTED BUT THE ERROR DID NOT CLEAR OUT. THIS PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836697 ↗
• MalfunctionNov 5, 2024Power Problem; Appropriate Device Problem Term/Code Not Available; Power Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT THE CONSOLE SYSTEM'S AIMING BEAM IS NOT CORRECTLY ALIGNED, AND THE SYSTEM IS NOT OUTPUTTING THE CORRECT AMOUNT OF ENERGY. THERE WAS NO PATIENT INVOLVED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608459 ↗