Harmonic HAR745Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705036035787), received between Nov 6, 2024 and Mar 30, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Separation

  IT WAS REPORTED THAT DURING THE CONVERSION OF SLEEVE TO BYPASS PROCEDURE, THE ACTIVE BLADE OF THE HARMONIC DEVICE BROKE, AND A PIECE OR REMNANT FELL OFF INTO THE PATIENT'S BODY, BUT IT WAS RETRIEVED. NO X-RAY WAS DONE BUT THEY WERE ABLE TO VISUALLY SEE THE REMNANT AND RETRIEVED IT. THE PATIENT IS DOING FINE NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731157 ↗
• MalfunctionMar 13, 2026Failure to Read Input Signal

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SCREEN OF THE GENERATOR WAS GIVING THE RELAX PRESSURE ERROR CODE EVEN THOUGH THE JAWS WERE OPEN. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591486 ↗
• MalfunctionFeb 12, 2026

  SURGEON TRIED USING THE HARMONIC 700 SERIES SHEARS, BUT THE DEVICE WAS NOT FUNCTIONAL AND WOULD NOT SEAL. A SECOND HARMONIC 700 SERIES SHEARS WAS OPENED AND WAS FUNCTIONAL. MINIMAL DELAY, NO IDENTIFIED HARM.

  Patient problems: Failure to Anastomose

  MAUDE report 24321481 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THAT THERE WAS A LOT BLEEDING/OOZING ON THE STAPLE LINE. A CLIP APPLIER WAS USED TO STOP THE BLEEDING/OOZING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24162468 ↗
• MalfunctionSep 8, 2025Material Separation; Material Separation

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THAT THE ACTIVE BLADE FELL COMPLETELY OFF. BLADE WAS RETRIEVED AND THE DEVICE WAS CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993038 ↗
• MalfunctionJun 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOR A CLINICAL TRIAL PATIENT (B)(6) DURING A UPPER GASTROINTESTINAL PROCEDURE THE PATIENT EXPERIENCED SUBCUTANEOUS EMPHYSEMA OF THE CHEST WALL, DYSPHAGIA, PNEUMONIA, AND LEFT PLEURAL EFFUSION. THE SUBCUTANEOUS EMPHYSEMA OF THE CHEST WALL HAS A CAUSAL RELATIONSHIP WITH THE PROCEDURE AND NOT RELATED TO THE DEVICE. THE DYSPHAGIA HAS A CAUSAL RELATIONSHIP WITH THE PROCEDURE AND NOT RELATED TO THE DEVICE. THE PNEUMONIA HAS A POSSIBLE RELATIONSHIP WITH THE PROCEDURE AND NOT RELATED TO THE DEVICE. IT WAS TREATED WITH DRUG THERAPY. THE LEFT PLEURAL EFFUSION HAS A CAUSAL RELATIONSHIP WITH THE PROCEDURE AND NOT RELATED TO THE DEVICE. IT WAS TREATED WITH A PIGTAIL CHEST TUBE INSTALLATION

  Patient problems: Pleural Effusion; Pneumonia; Unspecified Tissue Injury

  MAUDE report 22166263 ↗
• MalfunctionJan 24, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED PRIOR TO AN UNKNOWN PROCEDURE THE WHITE INNER BOXES THE PLASTIC IS BROKE AND AIR IS BEING LET IN. AT THE TIME OF THE CALL IT WAS UNKNOWN IF THE BROWN OUTER BOX WAS DAMAGED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232761 ↗
• MalfunctionJan 24, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED PRIOR TO AN UNKNOWN PROCEDURE THE WHITE INNER BOXES THE PLASTIC IS BROKE AND AIR IS BEING LET IN. AT THE TIME OF THE CALL IT WAS UNKNOWN IF THE BROWN OUTER BOX WAS DAMAGED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232738 ↗
• MalfunctionNov 6, 2024Material Separation; Noise, Audible; Material Separation; Noise, Audible

  IT WAS REPORTED THAT, AT THE END OF THE MYOMECTOMY OPERATION, THE ACTIVE BRANCH BROKE OFF. ACCORDING TO THE USER, THE GENERATOR EMITTED A DIFFERENT SOUND BEFORE THE BRANCH BROKE. IT IS NOT CLEAR WHETHER THE BROKEN PART WAS REMOVED AS A SUCTION CUP WAS USED DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621217 ↗