Harmonic ACERecalls & reported problems across all models
Ethicon Endo-Surgery, LLC · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12,862
- Deaths reported
- 5
- Injuries reported
- 123
- Recalls
- 0
We found 9 models of Harmonic ACE by Ethicon Endo-Surgery, LLC in the FDA's device registry (GUDID). Together they are named in 12,862 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2015 and Sep 30, 2026 — classified as 5 deaths, 123 injuries, 12,734 malfunctions.
The most frequently reported specific device problem is “Material Separation” (3,560 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Harmonic ACE problems
Device problems
- Material Separation3,560
- Failure to Read Input Signal2,159
- Detachment of Device or Device Component1,973
- Break1,324
- Difficult or Delayed Activation703
- Material Integrity Problem543
- Inappropriate or Unexpected Reset417
- Activation, Positioning or Separation Problem391
Patient problems
- No Clinical Signs, Symptoms or Conditions9,073
- No Consequences Or Impact To Patient3,695
- No Code Available44
- Hemorrhage/Blood Loss/Bleeding35
- Blood Loss31
- Insufficient Information13
- Not Applicable11
- Foreign Body In Patient10
Harmonic ACE models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Harmonic ACE HARH36Instrument, ultrasonic surgical4 deaths7,609 reports
- Harmonic ACE HAR36Instrument, ultrasonic surgical2,726 reports
- Harmonic ACE HARH23Instrument, ultrasonic surgical935 reports
- Harmonic Ace ACE36EInstrument, ultrasonic surgical860 reports
- Harmonic ACE HAR23Instrument, ultrasonic surgical1 death337 reports
- Harmonic ACE HARH45Instrument, ultrasonic surgical335 reports
- Harmonic Ace ACE23EInstrument, ultrasonic surgical38 reports
- Harmonic Ace ACE45EInstrument, ultrasonic surgical18 reports
- Harmonic Ace ACE14SInstrument, ultrasonic surgical4 reports
Recent Harmonic ACE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951194 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949903 ↗MalfunctionSep 30, 2026Failure to Read Input Signal; Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947839 ↗MalfunctionSep 29, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938424 ↗MalfunctionSep 29, 2026Material Separation
It was reported that during a Liver Resection procedure the titanium tip broke off. The broken piece was retrieved by forceps and was discarded. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935635 ↗MalfunctionSep 29, 2026Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934273 ↗MalfunctionSep 29, 2026Failure to Read Input Signal
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934016 ↗MalfunctionSep 29, 2026Smoking; Material Integrity Problem
It was reported that during an unknown procedure there was lots of smoke found. Then the tissue pad melted. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931148 ↗MalfunctionSep 28, 2026Activation, Positioning or Separation Problem
It was reported that during a Lobectomy procedure the scalpel was hard to cut. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923256 ↗MalfunctionSep 28, 2026Material Separation
It was reported that during a Hepatectomy procedure the titanium tip broke off. The broken piece was retrieved by forceps and was discarded. Changed to another device to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923218 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923038 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922336 ↗MalfunctionSep 28, 2026Material Separation
It was reported that during an unknown event the titanium tip broke off. The broken piece was retrieved by forceps and was discarded. Changed another one to complete surgery. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921765 ↗MalfunctionSep 28, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919356 ↗MalfunctionSep 28, 2026Failure to Read Input Signal; Difficult or Delayed Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918251 ↗
Other Ethicon Endo-Surgery, LLC products
- ECHELON FLEX7 models · 9,393 reports · 1 recall
- Harmonic13 models · 8,752 reports · 2 recalls
- ECHELON ENDOPATH31 models · 6,543 reports · 2 recalls
- LIGACLIP26 models · 3,254 reports
- ENDOPATH37 models · 2,785 reports
- ECHELON CIRCULAR4 models · 2,532 reports
- ECHELON Flex ENDOPATH7 models · 2,334 reports
- PROXIMATE41 models · 2,027 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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