EdgeRecalls & reported problems across all models
Covidien LP · 43 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 682
- Deaths reported
- 1
- Injuries reported
- 93
- Recalls
- 0
We found 43 models of Edge by Covidien LP in the FDA's device registry (GUDID). Together they are named in 682 adverse event reports in the FDA's MAUDE database, received between Mar 6, 2017 and Sep 16, 2026 — classified as 1 death, 93 injuries, 588 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (270 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 Edge problems
Device problems
- Peeled/Delaminated270
- Detachment of Device or Device Component221
- Adverse Event Without Identified Device or Use Problem132
- Fire113
- Arcing48
- Melted35
- Material Fragmentation31
- Detachment Of Device Component19
Patient problems
- No Clinical Signs, Symptoms or Conditions308
- No Consequences Or Impact To Patient118
- Burn(s)68
- Insufficient Information63
- Partial thickness (Second Degree) Burn25
- Superficial (First Degree) Burn22
- Foreign Body In Patient18
- No Code Available18
Edge models
43 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Edge E1455ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES238 reports
- Edge E2450HELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES52 reports
- Edge E1455NSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES51 reports
- Edge E2350HELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES40 reports
- Edge SDK4000-FTSystem, x-ray, tomography, computed32 reports
- Edge E1455-6ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES31 reports
- Edge E1455-4ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES30 reports
- Edge E2450HGNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES29 reports
- Edge E1465ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES20 reports
- Edge E2350HGNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES19 reports
- Edge SDK4900-FTSystem, x-ray, tomography, computed14 reports
- Edge E1450-4Electrosurgical, cutting & coagulation & accessories14 reports
- Edge E1450-6ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES12 reports
- Edge E1450XELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES12 reports
- Edge SD300LGSystem, x-ray, tomography, computed10 reports
- Edge E1455-4NSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES9 reports
- Edge SD180EWCTE-FTSystem, x-ray, tomography, computed8 reports
- Edge SDK4190-FTSystem, x-ray, tomography, computed1 death6 reports
- Edge E1450GELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- Edge E2450HNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- Edge E1455-6NSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- Edge E1450XNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- Edge E1450-6NSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Edge SDKM-FTSystem, x-ray, tomography, computed3 reports
- Edge E1452-6ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Edge E2350HNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Edge SDK4450-FTSystem, x-ray, tomography, computed2 reports
- Edge E1455BELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Edge E1465-4ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Edge E1465-6ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Edge E1475XELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Edge E2450HSELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Edge E1455BNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Edge E1551XNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Edge E1450GNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Edge SD300BASystem, x-ray, tomography, computed1 report
- Edge SD303BASystem, x-ray, tomography, computed1 report
- Edge SD45EWCTE-FTSystem, x-ray, tomography, computed1 report
- Edge SD90EWCTE-FTSystem, x-ray, tomography, computed1 report
- Edge SDSEWCTE-FTSystem, x-ray, tomography, computed1 report
- Edge E1465B-4ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Edge E1452ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Edge E2450HDBNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent Edge adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Entrapment of Device
It was reported that during a procedure, the device's tip was tearing the patient's skin. Another insulated tip was opened worked effectively.
Patient problems: Skin Tears
MAUDE report 50786689 ↗MalfunctionSep 16, 2026Entrapment of Device
It was reported that during a procedure, the device's tip was tearing the patient's skin. Another insulated tip was opened worked effectively.
Patient problems: Skin Tears
MAUDE report 50786568 ↗MalfunctionSep 16, 2026Entrapment of Device
It was reported that during a procedure, the device's tip was tearing the patient's skin. Another insulated tip was opened worked effectively.
Patient problems: Skin Tears
MAUDE report 50786454 ↗MalfunctionSep 10, 2026Peeled/Delaminated; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714422 ↗MalfunctionAug 20, 2026Peeled/Delaminated; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50336074 ↗MalfunctionAug 11, 2026Peeled/Delaminated; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
Patient problems: Superficial (First Degree) Burn; Tissue Breakdown
MAUDE report 50205127 ↗MalfunctionJul 30, 2026Peeled/Delaminated; Detachment of Device or Device Component; Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50091254 ↗MalfunctionJul 9, 2026
THE PROVIDER WAS USING A COVIDIEN BLADE ELECTRODE 4" BOVIE DURING A CASE, AND DURING THE USE OF THE BOVIE, THE TIP CAUGHT FIRE, WITH A SMALL FLAME APPEARING. THE PROVIDER NOTICED IMMEDIATELY, AND WAVED THE BOVIE IN THE AIR AND THE FLAME WAS QUICKLY EXTINGUISHED. THE BOVIE WAS UNPLUGGED AND PUT TO THE SIDE, AND ANOTHER PLUGGED IN AND USED WITHOUT ISSUE FOR THE REMAINDER OF THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25769438 ↗MalfunctionJun 16, 2026Peeled/Delaminated; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PROCEDURE THE TRANSPARENT PLASTIC OF THE DEVICE CAME LOOSE FROM THE COAGULATION TIP AND ENDED UP IN THE PATIENT. THE SURGEONS (2) IMMEDIATELY NOTICED THIS PART AND REMOVED IT. THE SMALL, TRANSPARENT TUBULAR PLASTIC SHEATH DOES NOT HOLD ANOTHER SMALL SHEATH AS TRANSPARENT, WHICH EASILY DETACHES FROM THE INSTRUMENT AND FALLS OFF. NO X-RAY WAS REQUIRED TO ASSIST IN LOCATION THE PIECE. NO SIGNIFICANT EXTENSION OF THE DURATION OF THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25514886 ↗MalfunctionJun 4, 2026Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A BREAST CASE, THE SURGEON REGULARLY REMOVED AND REINSERTED THE BOVIE TIP TO CLEAR THE SUCTION COMPONENT OF THE COMBINATION SUCTION/CAUTERY DEVICE. THIS REPEATED REMOVAL AND REINSERTION WAS ROUTINE AND NECESSARY, AND THE SAME BOVIE TIP WAS REUSED THROUGHOUT THE CASE. IN THAT INSTANCE, THE SURGEON OBSERVED A SMALL AREA OF SKIN BURNING AT A TIME WHEN THE TIP WAS BELIEVED TO BE WELL BEYOND THE SKIN INCISION AND SHOULD NOT HAVE CAUSED AN INJURY. UPON INSPECTION, THE SURGEON NOTED HOLES IN THE INSULATION NEAR THE BASE OF THE BOVIE TIP, SUGGESTING THAT THE NORMALLY INSULATED PORTION MAY HAVE CONTACTED THE SKIN WHILE THE ACTIVE TIP WAS DEEPER IN THE INCISION.
Patient problems: Burn(s)
MAUDE report 25392037 ↗MalfunctionMay 27, 2026Peeled/Delaminated; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PLASTIC INSULATION COVER FROM CAUTERY PENCIL INSULATED TIP FELL OFF. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25296389 ↗MalfunctionMay 24, 2026Peeled/Delaminated; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE, THE CLEAR INSULATED BOVIE TIP SHEATH HAS FALLEN OFF. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25267264 ↗MalfunctionMay 20, 2026Peeled/Delaminated; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO USE, THE ELECTRODE'S INSULATED TIP THAT SHOULD STAY CONNECTED TO CAUTERY WAS FALLING OFF WHEN REMOVING COVER OF CAUTERY AND WAS STUCK INSIDE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230041 ↗MalfunctionMay 19, 2026Peeled/Delaminated; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE, THE CLEAR INSULATED BOVIE TIP SHEATH HAS FALLEN OFF. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25218136 ↗MalfunctionMay 19, 2026Peeled/Delaminated; Detachment of Device or Device Component; Insufficient Device Problem Information
IT WAS REPORTED THAT THE CLEAR INSULATED BOVIE TIP SHEATH HAS FALLEN OFF.
Patient problems: Insufficient Information
MAUDE report 25218042 ↗
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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