SonicisionRecalls & reported problems across all models
Covidien LP · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Sonicision model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,403
- Deaths reported
- 2
- Injuries reported
- 131
- Recalls
- 2
We found 16 models of Sonicision by Covidien LP in the FDA's device registry (GUDID). Together they are named in 1,403 adverse event reports in the FDA's MAUDE database, received between May 9, 2016 and Sep 30, 2026 — classified as 2 deaths, 131 injuries, 1,270 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (781 reports).
2 FDA recall records name at least one of these models by its device identifier, 1 still open.
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
Sonicision recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 12, 2021Open, Classified
Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
Z-0332-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 23, 2021Terminated
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located
Z-2240-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Sonicision problems
Device problems
- Detachment of Device or Device Component781
- Failure to Fire341
- Intermittent Energy Output166
- Detachment Of Device Component134
- Break122
- Material Fragmentation78
- Adverse Event Without Identified Device or Use Problem64
- Difficult to Open or Close61
Patient problems
- No Consequences Or Impact To Patient651
- No Clinical Signs, Symptoms or Conditions552
- No Patient Involvement58
- No Information45
- Insufficient Information32
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available23
- Hemorrhage/Blood Loss/Bleeding21
- Device Embedded In Tissue or Plaque10
Sonicision models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sonicision SCD396Instrument, ultrasonic surgical1 death675 reports
- Sonicision SCDA39Instrument, ultrasonic surgical1 death355 reports
- Sonicision SCD391Instrument, ultrasonic surgical188 reports
- Sonicision SCD26Instrument, ultrasonic surgical67 reports
- Sonicision SCGAAInstrument, ultrasonic surgical1 recall4 reports
- Sonicision CBCAInstrument, ultrasonic surgical1 recall0 reports
- Sonicision SCD48Instrument, ultrasonic surgical30 reports
- Sonicision SCDA26Instrument, ultrasonic surgical30 reports
- Sonicision SCDA48Instrument, ultrasonic surgical14 reports
- Sonicision SCD13Instrument, ultrasonic surgical12 reports
- Sonicision SCDA13Instrument, ultrasonic surgical12 reports
- Sonicision SCD396Instrument, ultrasonic surgical9 reports
- Sonicision SCBAInstrument, ultrasonic surgical3 reports
- Sonicision SCBAInstrument, ultrasonic surgical2 reports
- Sonicision SCD391Instrument, ultrasonic surgical1 report
- Sonicision SCD13Instrument, ultrasonic surgical1 report
Recent Sonicision adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949235 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
It was reported that, during procedure, the doctor noted that the device had been weakened and the tip ended up breaking off while tissue was being dissected. There was no patient harm/injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948237 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940807 ↗MalfunctionSep 25, 2026Failure to Deliver Energy; Peeled/Delaminated; Failure to Cut; Detachment of Device or Device Component
It was reported that, during procedure, the device presented a defect in cut and coagulation and the Teflon presented failure detaching from the jaws of the device. The device was immediately replaced. There was no patient harm/injury. Photo observation showed the jaw liner sliding midway of the jaw. Medtronic's initial evaluation of the incident device found the jaw liner was removed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903722 ↗MalfunctionSep 25, 2026Failure to Fire; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903703 ↗MalfunctionSep 25, 2026Failure to Fire; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903110 ↗MalfunctionSep 25, 2026Peeled/Delaminated; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902901 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
It was reported that, during procedure, the dissector after use, it was placed on the instrument table an a sound was heard. Upon checking it was found that an included metal rod like object had fallen off. There was no component dropped into the abdominal cavity, and there were no issues with use. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849979 ↗MalfunctionSep 21, 2026Failure to Fire; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849015 ↗MalfunctionAug 28, 2026Detachment of Device or Device Component; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50494251 ↗MalfunctionJun 25, 2026Failure to Fire; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR BROKE DURING USE ON A PATIENT AND HAD RED LIGHT. IT WAS WORKING INTERMITTENTLY PRIOR TO DISENGAGEMENT. THE TOP OF THE JAW HAD BROKE AND ALL PIECES WERE RETRIEVED. THERE WAS NO PIECE THAT FALL INTO THE PATIENT CAVITY. THE DEVICE WAS NOT BROKEN DURING CLEANING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25626401 ↗MalfunctionJun 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE MIDDLE OF THE PROCEDURE, THE DISSECTOR'S TOP OF JAW HAD BROKE DURING USE ON PATIENT. RED LIGHT WAS OBSERVED. THE DEVICE WAS WORKING INTERMITTENTLY PRIOR TO THE DISENGAGEMENT OF THE PIECE. THERE WAS NO ANY PIECE FALL INTO THE PATIENT CAVITY. ALL PIECES WERE RETRIEVED. X-RAY WAS NOT NECESSARY. IT DID NOT BREAK DURING CLEANING. IT WAS REPLACED WITH A NEW DISSECTOR TO COMPLETE THE PROCEDURE. THERE WAS NO ANY ADDITIONAL PROCEDURE NEEDED TO REMOVE THE PIECE FROM THE PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428990 ↗MalfunctionApr 14, 2026Difficult to Open or Close
IT WAS REPORTED THAT DURING A PROCEDURE, THE JAWS OF THE HANDPIECE DID NOT OPEN. ANOTHER HANDPIECE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872684 ↗MalfunctionMar 25, 2026Failure to Fire; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PROCEDURE, AFTER APPROXIMATELY 20 MINUTES OF FUNCTIONING THE DEVICE HAD A RED LIGHT. THE BATTERY AND GENERATOR WERE REPLACED BUT THE ISSUE REMAINED. ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR AND THE SAME BATTERY AND IT WORKED FINE. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. NO PART OF THE DISSECTOR BROKE OR DETACHED. THE CHARGER WAS NOT WORKING AS WELL AND THE INDICATOR LIGHTS ON THE CHARGER WAS RED. THE SAME BATTERY WAS ABLE TO BE CHARGED IN A DIFFERENT BAY. THERE WAS NO PATIENT HARM/INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A BROKEN WAVEGUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24686708 ↗MalfunctionMar 18, 2026Failure to Cut; Difficult to Open or Close; Intermittent Energy Output
IT WAS REPORTED DURING THE LAPAROSCOPIC COLECTOMY, THE PHYSICIAN CLOSED THE DEVICE, SEALED, THEN WENT TO CUT AND RELEASE, BUT IT WOULD NOT CUT AND RELEASE FROM ILEOCOLIC VASCULAR PEDICLE AFTER 20 MINUTES OF THE PROCEDURE. THE DEVICE'S KNIFE BLADE WAS EXTENDED. THE DEVICE WAS RELEASED FROM THE TISSUE BY FORCEFULLY PULLING THE HANDLES APART. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629100 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
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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