AcuPulse™Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 07290109140308), received between Mar 18, 2020 and Aug 11, 2026 — classified as 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (7 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Nonstandard Device; Unexpected Shutdown

  It was reported that during a procedure, the emergency stop switch is difficult to release and occasionally the console restarts during operation. The procedure was completed without patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211007 ↗
• MalfunctionApr 17, 2026Smoking

  IT WAS REPORTED THAT BEFORE THE PROCEDURE, A BURNT SMELL WAS FOUND WHEN THE DEVICE WAS TURNED ON. THE PROCEDURE WAS FINALLY COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911903 ↗
• MalfunctionMar 2, 2026Failure to Align

  IT WAS REPORTED THAT DURING PROCEDURE, THE AIMING BEAM DOES NOT ALIGN WITH THE CENTER WHEN USING ACUSPOT. THERE WAS A POSSIBILITY THAT THE CONSOLE'S ARM ALIGNMENT WAS OFF. THE ISSUE WAS RESOLVED BY RECONNECTING THE ACUPULSE ARM. IT WAS COMMUNICATED THAT THERE IS NO PROBLEM IF THE JOYSTICK ROTATES AROUND ONCE AND DOES NOT BREAK. NO PATIENT OR PROCEDURE OUTCOME INFORMATION HAVE BEEN PROVIDED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489605 ↗
• MalfunctionFeb 23, 2026Fire; Nonstandard Device; Output below Specifications

  IT WAS REPORTED THAT DURING PREPARATION FOR PROCEDURE, IT WAS NOTICED THAT THE DEVICE WAS SEVERELY CARBONIZED AND HAD INSUFFICIENT POWER, THE AIMING LIGHT WAS ALSO DIVERGING. THERE WAS A PATIENT INVOLVED AT THE TIME OF EVENT, HOWEVER, THERE IS NO INFORMATION RELATED TO PATIENT NOR PROCEDURE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420916 ↗
• MalfunctionDec 29, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE THE CONSOLE DISPLAYED ERROR 12 (CO2 COOLING FLOW SWITCH ERROR). THERE WERE NO PATIENT COMPLICATIONS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23914201 ↗
• MalfunctionNov 25, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE CONSOLE HAD INSUFFICIENT POWER OUTPUT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641714 ↗
• MalfunctionNov 21, 2025Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS A BURNING SMELL. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT AND PROCEDURE INVOLVEMENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622165 ↗
• MalfunctionOct 22, 2025Nonstandard Device; Failure to Align; Nonstandard Device; Failure to Align

  IT WAS REPORTED THAT, WHEN THE OTO LAM IS USED, THE AIMING BEAM AND THE RADIATION POSITIONS BECOME MISALIGNED. IT HAS IMPROVED THROUGH REDOCKING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363697 ↗
• MalfunctionAug 28, 2025Nonstandard Device; Use of Device Problem; Nonstandard Device; Use of Device Problem

  IT WAS REPORTED THAT THE CONSOLE HAS AN EMERGENCY BUTTON FAILURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919265 ↗
• MalfunctionAug 12, 2025Display or Visual Feedback Problem; Defective Device; Display or Visual Feedback Problem; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SCREEN DISPLAYED DOES NOT REACT. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE EVENT COULD NOT BE COMPLETED DUE TO THIS EVENT. THIS EVENT IS BEING REPORTED FOR AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786275 ↗
• MalfunctionJul 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE AIMING BEAM AND IRRADIATION POSITIONS ARE MISALIGNED. THE AIMING BEAM WAS CONSIDERED MISALIGNED BASED ON THE PHYSICIAN DISCRETION, AS IT WAS OBSERVED TO BE SLIGHTLY TO THE RIGHT OF THE AIMING POINT, ALTHOUGH IT WAS NOT FIRING IN AN INCORRECT DIRECTION. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663980 ↗
• MalfunctionJul 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A MISALIGNMENT BETWEEN THE CONSOLE AND THE AIMING BEAM. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502482 ↗
• MalfunctionJun 23, 2025Adverse Event Without Identified Device or Use Problem; Output below Specifications; Adverse Event Without Identified Device or Use Problem; Output below Specifications

  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS FOUND THAT THE AIMING LIGHT AND THE LASER DID NOT OVERLAP. HOWEVER, IT WAS CONFIRMED THAT THE AIMING BEAM WAS ALONG THE DIRECTION WITH THE LASER, AND THE AIMING BEAM WAS DIM. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. FIELD SERVICES OF THE CONSOLE IDENTIFIED THAT THE LASER AND AIMING BEAM ALIGNMENT NEEDED TO BE ADJUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308438 ↗
• MalfunctionApr 25, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT, CONSOLE HAD A WEAK OUTPUT. IT WAS NOTED THAT THE TISSUE WAS HARDER TO BURN THAN USUAL AND THE CASE SAVER MODE WAS NOT PROMPTED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914468 ↗
• MalfunctionMar 12, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ACUSPOT MIRROR FELL OUT. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THIS EVENT. 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 AN ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA OR WHOSE SEDATION STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21588936 ↗
• MalfunctionFeb 28, 2025Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING PREPARATION OF A PROCEDURE, ERROR 74 (SCANNER POSITION Z AXIS ERROR) WAS DISPLAYED ON THE CONSOLE SCREEN. AS A RESULT, THERE WAS NO PROCEDURE. 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 OR UNKNOWN SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21495953 ↗
• InjuryJan 21, 2025Failure to Power Up; Device Displays Incorrect Message; Failure to Power Up; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE VOCAL CORD POLYPECTOMY SURGERY, THE CONSOLE REPORTED ERROR 74 (SCANNER POSITIONING ERROR); AFTER RESTARTING ACCORDING TO THE PROMPTS, THE DEVICE COULD NOT BE TURNED ON AND USED, WHICH AFFECTS THE SURGICAL PROCESS. DURING THE OPERATION, THE LASER CUTTING OF VOCAL CORD POLYPS WAS TEMPORARILY CHANGED TO ENUCLEATION, WHICH INCREASES THE DIFFICULTY OF THE OPERATION FOR DOCTORS DUE TO THE PATIENT'S WOUND BECAME LARGER. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 21197435 ↗
• MalfunctionJan 20, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION FOR PROCEDURE, IT WAS CONFIRMED THAT THE SELF-EXAMINATION COULD NOT BE PERFORMED. THE PROCEDURE WAS RESCHEDULED FOR ANOTHER DAY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21194194 ↗
• MalfunctionJan 13, 2025Failure to Align; Defective Device; Failure to Align; Defective Device

  IT WAS REPORTED THAT DURING PROCEDURE THERE WAS AN ISSUE WITH A SECONDARY BEAM, THERE IS A MICROMANIPULATOR THAT MAY NEED THE MIRROR TO BE CHANGED. AND IT IS BELIEVED THAT IT COULD ALSO BE MISALIGNMENT. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144178 ↗
• MalfunctionNov 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE AIMING BEAM WAS DEVIATED 2-3 MM. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT INVOLVEMENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787038 ↗
• MalfunctionJun 24, 2024Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE POWER IS WEAK. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19599624 ↗
• MalfunctionJun 7, 2024Adverse Event Without Identified Device or Use Problem; Optical Problem; Output below Specifications; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Optical Problem; Output below Specifications; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE FIRING LASER BEAM ALIGNMENT WAS OFF, AND THE AIMING BEAM IS BARELY VISIBLE IN LOW LIGHT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484473 ↗
• MalfunctionMar 6, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING PREVENTIVE MAINTENANCE, THE AIMING BEAM WAS IDENTIFIED AS TO BE NOT CONSTANT IN THE MIDDLE OF THE ARM. IT MOVES OVER THE COMPLETE OUTCOME. AS A CONSEQUENCE, THE LASER OCCASIONALLY STRIKES THE END OF THE ARM UNDER SPECIFIC CONDITIONS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846843 ↗
• MalfunctionMar 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS AN EMERGENCY STOP BUTTON FAILURE AND THE BUTTON IS ALSO NOT FITTING PROPERLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO FURTHER INFORMATION ABOUT THE PATIENT AND PROCEDURE OUTCOME ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832882 ↗
• MalfunctionFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A DOCTOR ACCIDENTALLY STEPPED ON THE FOOTSWITCH, CAUSING THE DRAPE TO CATCH FIRE. THE CUSTOMER THINKS THEY SHOULD SWITCH READY/STANDBY EACH TIME IRRADIATION IS PERFORMED TO PREVENT IRRADIATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18713500 ↗