BISRecalls & reported problems across all models
Covidien LP · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 337
- Deaths reported
- 2
- Injuries reported
- 9
- Recalls
- 0
We found 19 models of BIS by Covidien LP in the FDA's device registry (GUDID). Together they are named in 337 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2017 and Sep 28, 2026 — classified as 2 deaths, 9 injuries, 326 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (121 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 BIS problems
Device problems
- Incorrect Measurement121
- Patient Device Interaction Problem46
- High Readings43
- Temperature Problem39
- Low Readings38
- Device Damaged Prior to Use19
- Device Alarm System18
- Image Display Error/Artifact18
Patient problems
- No Clinical Signs, Symptoms or Conditions154
- Insufficient Information104
- No Consequences Or Impact To Patient21
- Skin Inflammation/ Irritation8
- Pressure Sore/Ulcer6
- Awareness During Anesthesia5
- Erythema5
- No Patient Involvement5
BIS models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIS 186-0106Electrode, Cutaneous1 death105 reports
- BIS 186-1046Index-generating electroencephalograph software102 reports
- BIS 186-0224-AMSIndex-generating electroencephalograph software1 death41 reports
- BIS 186-0195-AMSIndex-generating electroencephalograph software38 reports
- BIS 186-0195-NKIndex-generating electroencephalograph software11 reports
- BIS 186-1001-RFBIndex-generating electroencephalograph software6 reports
- BIS 186-0199-RFBIndex-generating electroencephalograph software5 reports
- BIS 186-0200Electrode, Cutaneous5 reports
- BIS PMB4000Index-generating electroencephalograph software5 reports
- BIS 186-0299-RFBIndex-generating electroencephalograph software4 reports
- BIS PMB4000DOCReduced- montage standard electroencephalograph4 reports
- BIS 186-0195-GEIndex-generating electroencephalograph software2 reports
- BIS 186-0195-DMIndex-generating electroencephalograph software2 reports
- BIS 186-0106-PHIndex-generating electroencephalograph software2 reports
- BIS 186-0195-PHIndex-generating electroencephalograph software1 report
- BIS DL186-1046Index-generating electroencephalograph software1 report
- BIS 186-0224-PHIndex-generating electroencephalograph software1 report
- BIS PMB4000ACBLIndex-generating electroencephalograph software1 report
- BIS 186-0160ELECTRODE, CUTANEOUS1 report
Recent BIS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Analyze Signal
Patient problems: Unspecified Tissue Injury
MAUDE report 50926550 ↗MalfunctionSep 22, 2026Incorrect Measurement
Patient problems: Insufficient Information
MAUDE report 50860275 ↗MalfunctionAug 27, 2026Incorrect Measurement
It was reported that the device was not measuring correctly. It was unknown if there was any patient involvement or complications as a result of the event.
Patient problems: Insufficient Information
MAUDE report 50479485 ↗MalfunctionAug 25, 2026Incorrect Measurement
It was reported that incorrect readings were observed with the product. It was unknown if there was any patient involvement or complications as a result of the event.
Patient problems: Insufficient Information
MAUDE report 50438997 ↗MalfunctionAug 5, 2026Image Display Error/Artifact; Temperature Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140727 ↗MalfunctionJun 24, 2026Incorrect Measurement; Unable to Obtain Readings
IT WAS REPORTED THAT THE MODULE HAD WRONG VALUES AND READING VALUES DISCONTINUOUSLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 25615875 ↗MalfunctionJun 23, 2026Incorrect Measurement; Communication or Transmission Problem
IT WAS REPORTED THAT DURING USE, THE WAVEFORM WAS DISORDERED AND IRREGULAR AND THE SIGNAL COULD NOT BE DETECTED NORMALLY. THE SCREEN SHOWED GARBLED CHARACTERS. THE DEVICE WAS IMMEDIATELY DISCONTINUED AND REPLACED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25589852 ↗MalfunctionJun 20, 2026Unable to Obtain Readings; High Readings; Communication or Transmission Problem
IT WAS REPORTED THAT THE SENSOR HAD NO READING. SENSOR NUMBER 3 WAS SPECIFICALLY REPORTED AS NOT BEING RECOGNIZED AND HAVING CONSISTENTLY HIGH READINGS. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 25568991 ↗MalfunctionJun 16, 2026Failure to Run on Battery; Temperature Problem
IT WAS REPORTED THAT PRIOR TO USE, THE MONITOR AND DOCKING STATION WOULD NOT CHARGE, BUT UPON INSPECTION, IT WAS FOUND THAT THE BOTTOM OF THE DOCKING STATION WHERE THE CHARGER WAS CONNECTED BURNT. NO SMOKE WAS SEEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523251 ↗MalfunctionJun 10, 2026Communication or Transmission Problem; Temperature Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT THE DEVICE WAS NOT RECOGNIZED BY THE MONITOR, AND THE DEVICE WIRE WAS PEELED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE OUTCOME. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE PRINTED CIRCUIT BOARD SMELLED LIKE BURNING.
Patient problems: Insufficient Information
MAUDE report 25457410 ↗MalfunctionJun 1, 2026Use of Device Problem
IT WAS REPORTED THAT DURING PROCEDURE, THE MONITOR HAD A READING OF 43, HOWEVER, THE PATIENT EXPERIENCED AN EPISODE OF INTRAOPERATIVE AWARENESS. FAILURE WAS ISOLATED TO THE MONITOR. IT WAS ALSO REPORTED THAT THE MODULE ALLEGEDLY WAS USED DURING THE PROCEDURE, HOWEVER IT DISPLAYED A DIFFERENT SERIAL NUMBER ON THE THE MONITOR. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348616 ↗MalfunctionMay 12, 2026Temperature Problem
IT WAS REPORTED THAT DURING USE, THE MONITOR WAS OPERATING NORMALLY, BUT AN IGNITION OCCURRED FROM THE POWER OUTLET AND DID NOT TURN BACK ON. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155899 ↗MalfunctionMay 4, 2026High Readings
IT WAS REPORTED THAT DURING USE, THE DEVICE HAD AN INTERFERENCE AND ABNORMALLY HIGH READINGS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25068322 ↗MalfunctionApr 16, 2026Patient Device Interaction Problem
IT WAS REPORTER THAT THE PATIENT USED THE SENSOR FOR APPROXIMATELY THREE HOURS AND LATER DEVELOPED BRUISING ON THE FOREHEAD. ON POSTOPERATIVE DAY ONE, A 3 CM AREA OF REDNESS WAS NOTED ON THE LEFT FOREHEAD WITHOUT ITCHING OR PAIN. SHORTLY AFTERWARD, THE PATIENT REPORTED REDNESS AND PAIN IN THE LEFT FRONTAL AREA. THE ATTENDING PHYSICIAN INITIALLY PRESCRIBED LINDELON VG, WHICH WAS LATER CHANGED TO LOCOID. ON DAY TWO, THREE RAISED, 3 CM LESIONS APPEARED ON THE FOREHEAD, STILL WITHOUT ITCHING. THE PATIENT REPORTED THAT THE RASH PERSISTED AND THAT LOCOID SEEMED INEFFECTIVE. A DERMATOLOGY CONSULT WAS ARRANGED. EXAMINATION SHOWED WELL-DEMARCATED EDEMATOUS ERYTHEMA AT THREE FOREHEAD SITES AND ONE ON THE LEFT TEMPLE. DELAYED PRESSURE URTICARIA WAS SUSPECTED, AND BETASEREMIN COMBINATION TABLETS AND NERIZONA UNIVERSAL OINTMENT WERE PRESCRIBED.
Patient problems: Bruise/Contusion
MAUDE report 24895537 ↗MalfunctionApr 9, 2026Insufficient Heating; Contamination /Decontamination Problem; Temperature Problem
IT WAS REPORTED THAT THE MONITOR SMELLED STRONGLY OF DEFECTIVE ELECTRONICS AND IT BECAME WARM. THE POWER CONNECTOR AND THE MAINS SOCKET ON THE MONITOR SHOWED RESIDUES OF LIQUID OR OILY SUBSTANCES. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.
Patient problems: Insufficient Information
MAUDE report 24831939 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page