LigaSureRecalls & reported problems across all models
Covidien LP · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7,283
- Deaths reported
- 11
- Injuries reported
- 426
- Recalls
- 1
We found 32 models of LigaSure by Covidien LP in the FDA's device registry (GUDID). Together they are named in 7,283 adverse event reports in the FDA's MAUDE database, received between Jan 26, 2016 and Sep 30, 2026 — classified as 11 deaths, 426 injuries, 6,845 malfunctions.
The most frequently reported specific device problem is “Energy Output Problem” (2,651 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
LigaSure 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.
- Dec 6, 2021Terminated
Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.
Z-0495-2022 · Root cause: Device Design · Recall details · FDA record ↗
Most reported LigaSure problems
Device problems
- Energy Output Problem2,651
- Difficult to Open or Close1,754
- Detachment of Device or Device Component835
- Retraction Problem796
- Peeled/Delaminated512
- Device Alarm System385
- Intermittent Energy Output369
- Energy Output To Patient Tissue Incorrect345
Patient problems
- No Clinical Signs, Symptoms or Conditions3,875
- No Consequences Or Impact To Patient2,166
- Insufficient Information460
- Hemorrhage/Blood Loss/Bleeding415
- No Information216
- No Patient Involvement130
- Blood Loss123
- No Known Impact Or Consequence To Patient83
LigaSure models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LigaSure LF1937Electrosurgical, cutting & coagulation & accessories3 deaths2,090 reports
- LigaSure LF1837ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall967 reports
- LigaSure LF2019Electrosurgical, cutting & coagulation & accessories948 reports
- LigaSure LF1923Electrosurgical, cutting & coagulation & accessories855 reports
- LigaSure LF5637ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 deaths525 reports
- LigaSure LF1737ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 deaths469 reports
- LigaSure LF1944Electrosurgical, cutting & coagulation & accessories1 death369 reports
- LigaSure LF1637ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES205 reports
- LigaSure LF5644ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES194 reports
- LigaSure LF1723ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 deaths109 reports
- LigaSure LS1500ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 death95 reports
- LigaSure LF1823ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES85 reports
- LigaSure LS1520ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES51 reports
- LigaSure LF1844ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES50 reports
- LigaSure LF1744ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES48 reports
- LigaSure LF1930TElectrosurgical, cutting & coagulation & accessories38 reports
- LigaSure LF1212AElectrosurgical, cutting & coagulation & accessories30 reports
- LigaSure LF1537ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES29 reports
- Ligasure LS3112ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES28 reports
- LigaSure LF1520ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES22 reports
- LigaSure LF3225ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES20 reports
- Ligasure LS3092ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES16 reports
- LigaSure LF1212AELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES10 reports
- LigaSure LF1623ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES8 reports
- LigaSure LF1644ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- LigaSure LF1544ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- LigaSure LF1212AELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- Ligasure LS2071ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Ligasure LS2111ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- LigaSure LigaSure 8ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- LigaSure LF3225CELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- LigaSure LF3225Electrosurgical, cutting & coagulation & accessories1 report
Recent LigaSure adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Difficult to Open or Close
Patient problems: Insufficient Information
MAUDE report 50955155 ↗MalfunctionSep 30, 2026Energy Output Problem; Failure to Cut
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50953335 ↗MalfunctionSep 30, 2026Energy Output Problem; Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950576 ↗MalfunctionSep 30, 2026Self-Activation or Keying
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949505 ↗MalfunctionSep 30, 2026Energy Output Problem; Intermittent Energy Output
It was reported that, during neck dissection on a thyroidectomy procedure, the device sealing can no longer be completed. There was no problem at the start of the procedure. Another device 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 50949251 ↗MalfunctionSep 30, 2026Device Remains Activated; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947000 ↗MalfunctionSep 30, 2026Energy Output Problem
It was reported that during a procedure, the device had no seal with no evidence of energy delivery observed and end tones heard. Another device was used successfully with the same generator. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946989 ↗MalfunctionSep 30, 2026Retraction Problem; Difficult to Open or Close
It was reported that, during a procedure, the knife blade could not retract, the device was difficult or impossible to open, and the device became stuck on tissue. The jaws were forced open to remove the device from tissue.
Patient problems: Insufficient Information
MAUDE report 50943021 ↗MalfunctionSep 30, 2026Energy Output Problem
It was reported that, during use, two devices were connected to a generator. One device had inadequate/partial vessel sealing despite evidence of energy delivery and end tones being heard. The other device activated without the activation button being pressed. Another device was used successfully with the generator. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942987 ↗MalfunctionSep 30, 2026Device Remains Activated; Communication or Transmission Problem
It was reported that during a Total Laparoscopic Hysterectomy intra-abdominal operation, the tactile switch did not return and remai ned in the pressed state. The device output unintentionally. A new device was used successfully. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941768 ↗MalfunctionSep 30, 2026Unintended Power Up
It was reported that prior to use, the device was unintentionally activated. A new device was successfully used. No patient was involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941709 ↗MalfunctionSep 30, 2026Retraction Problem; Protective Measures Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941440 ↗MalfunctionSep 29, 2026Difficult to Open or Close; Intermittent Energy Output
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941287 ↗MalfunctionSep 29, 2026Energy Output Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50936632 ↗MalfunctionSep 29, 2026Device Alarm System; Energy Output Problem
It was reported that, during procedure, the device was sealing inadequate with evidence of energy delivery and end tones heard. The seal showed evidence of energy delivery but bleeds after cutting. Another ligasure was used successfully with the same generator. There was a regrasp alarm. No surgical/medical interventions needed and no patient symptoms or complications related to the event. There was no patient harm/injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936423 ↗
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
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
- Puritan Bennett119 models · 3,169 reports · 18 recalls
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.
How reports and recalls are matched · Editorial policy · Report an error on this page