ValleylabRecalls & reported problems across all models
Covidien LP · 97 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 999
- Deaths reported
- 0
- Injuries reported
- 129
- Recalls
- 0
We found 97 models of Valleylab by Covidien LP in the FDA's device registry (GUDID). Together they are named in 999 adverse event reports in the FDA's MAUDE database, received between Jun 21, 2016 and Sep 30, 2026 — classified as 129 injuries, 870 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (113 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 Valleylab problems
Device problems
- Adverse Event Without Identified Device or Use Problem495
- Peeled/Delaminated113
- Self-Activation or Keying105
- Detachment of Device or Device Component96
- Fire92
- Arcing81
- Device Remains Activated50
- Melted39
Patient problems
- Burn(s)281
- No Clinical Signs, Symptoms or Conditions275
- No Consequences Or Impact To Patient98
- Superficial (First Degree) Burn89
- Partial thickness (Second Degree) Burn78
- Insufficient Information63
- Full thickness (Third Degree) Burn36
- No Patient Involvement35
Valleylab models
97 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Valleylab E7507ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES192 reports
- Valleylab SEP6000Electrosurgical, cutting & coagulation & accessories101 reports
- Valleylab E3781R-28ASPElectrosurgical, cutting & coagulation & accessories48 reports
- Valleylab E2100ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES47 reports
- Valleylab E2515HELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES45 reports
- Valleylab E1502ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES33 reports
- Valleylab CVPLP2000ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES32 reports
- Valleylab E2516HELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES32 reports
- Valleylab E2505-10FRELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES27 reports
- Valleylab E7509ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES27 reports
- Valleylab E2750ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES25 reports
- Valleylab E2781R-28ASPELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES22 reports
- Valleylab VL2610ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES21 reports
- Valleylab E2516HGNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES21 reports
- Valleylab SEP5000Electrosurgical, cutting & coagulation & accessories20 reports
- Valleylab E2515ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES14 reports
- Valleylab VL2610DBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES13 reports
- Valleylab E7507DBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES13 reports
- Valleylab E7506ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES13 reports
- Valleylab E7510-25ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES13 reports
- Valleylab SEP6015Electrosurgical, cutting & coagulation & accessories12 reports
- Valleylab CVPLP2000Electrosurgical, cutting & coagulation & accessories11 reports
- Valleylab E4051-CTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES11 reports
- Valleylab E6008LUnit, electrosurgical and coagulation, with accessories10 reports
- Valleylab E1551-6ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES9 reports
- Valleylab E3310Electrosurgical, cutting & coagulation & accessories9 reports
- Valleylab E2516ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES8 reports
- Valleylab E2515HGNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES8 reports
- Valleylab E6009UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES7 reports
- Valleylab E3783R-28ASPElectrosurgical, cutting & coagulation & accessories6 reports
- Valleylab E1564ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)6 reports
- Valleylab E2781-28ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- Valleylab E2520HELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- Valleylab E7509BELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- Valleylab E3773-36ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- Valleylab E1560ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)5 reports
- Valleylab E2515HDBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- Valleylab E0510ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- Valleylab E2401ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- Valleylab SEP6000NSBElectrosurgical, cutting & coagulation & accessories4 reports
- Valleylab E1561ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)4 reports
- Valleylab E4055-CTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- Valleylab E2608-6Electrosurgical, cutting & coagulation & accessories4 reports
- Valleylab E1650ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Valleylab E1651ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Valleylab E3520HElectrosurgical, cutting & coagulation & accessories3 reports
- Valleylab VLFT10FXGENElectrosurgical, cutting & coagulation & accessories3 reports
- Valleylab E1559ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)3 reports
- Valleylab E1562ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)3 reports
- Valleylab E0560ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Valleylab E3771-36ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E1551XELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E1552ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E3783R-36ASPElectrosurgical, cutting & coagulation & accessories2 reports
- Valleylab E3781-28Electrosurgical, cutting & coagulation & accessories2 reports
- Valleylab E4054-CTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E7508ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E7512ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E1504ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E2516HSELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E6008BUNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES2 reports
- Valleylab E6008UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES2 reports
- Valleylab E2999ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E3305ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E2516HNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E2515HDANSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Valleylab E1552-6ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E1654BELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab SEL7010Tubing/tubing with filter, insufflation, laparoscopic1 report
- Valleylab E3810Electrosurgical, cutting & coagulation & accessories1 report
- Valleylab E3530-3Electrosurgical, cutting & coagulation & accessories1 report
- Valleylab E10503Electrosurgical, cutting & coagulation & accessories1 report
- Valleylab E1563ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)1 report
- Valleylab E2530-28ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E2780-28ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E2783-28ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E2516HDAELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E2783R-28ASPELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E4052-CTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E4057-CTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E4058-CTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E4060-CTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E4073-CTELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E7510-25DBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E2504HELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E0020VELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E0021SELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E2608-6ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E3310ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E0502-1ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab Force Argon II-20ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab Force Argon II-8ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E2516GNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E2515HSNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E2515NSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E2515HNSBELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Valleylab E3305Electrosurgical, cutting & coagulation & accessories1 report
Recent Valleylab 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 50951500 ↗MalfunctionSep 30, 2026Self-Activation or Keying
Patient problems: Insufficient Information
MAUDE report 50950996 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Superficial (First Degree) Burn
MAUDE report 50849353 ↗MalfunctionAug 28, 2026Material Discolored; Device Damaged Prior to Receipt by User; Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50493831 ↗MalfunctionAug 4, 2026Peeled/Delaminated; Detachment of Device or Device Component
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50129143 ↗MalfunctionJun 23, 2026Contamination; Device Damaged Prior to Receipt by User; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PRIOR TO USE, UPON OPENING THE PACKAGE OF THE DEVICE, THE PRODUCT HAD NO ADHESIVE. THE PAD CONTAINED WHITE FOREIGN MATERIALS AS SHOWN IN THE PHOTO PROVIDED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THERE NO GEL NOTED ON THE FOIL OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25591856 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TWO HOURS AFTER THE PROCEDURE, A LESS THAN 3CMX3CM THIRD DEGREE BURN WHEN VIEWED WITH THE NAKED EYES WAS DISCOVERED ON THE PATIENT'S BUTTOCK AREA. THE PAD WAS ATTACHED ACROSS THE BACK AND BUTTOCKS AS THE PATIENT WAS A CHILD. IT WAS INITIALLY SEVERE BUT GRADUALLY RECOVERING AS ALL AVAILABLE BEST TREATMENTS LIKE DRESSING FOR BURN INJURY WERE PROVIDED FOR 3 WEEKS.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 25320638 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DURING CLAVICLE RAFI (OPEN REDUCTION AND INTERNAL FIXATION), THE PATIENT HAD A 3RD DEGREE BURN ON THE LEFT SIDE OF THE BACK COINCIDING WITH THE CLAVICLE PROCEDURE SIDE. THE ELECTROCAUTERY PLATE WAS PLACED ON THE RIGHT ARM, WITHOUT ANY PROBLEMS SENSING. THE BURN WAS TREATED WITH PLASTIC SURGERY. THE PATIENT REMAINS ADMITTED AT THE TIME OF THIS REPORT.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 25300785 ↗MalfunctionMay 27, 2026Failure to Deliver Energy; Device Remains Activated
IT WAS REPORTED THAT DURING CYSTOSCOPY AND BLADDER RESECTION PROCEDURE, THE MONOPOLAR FOOTSWITCH COAGULATION PEDAL WOULD NOT RELEASE WHEN SURGEON'S FOOT WAS REMOVED FROM DEPRESSING IT. THE FOOT PEDAL WHICH WAS ATTACHED TO THE MONOPOLAR RESECTING LOOP WAS STILL IN PATIENT'S BLADDER CONTINUED TO COAGULATE INSIDE THE PATIENT. SURGEON QUICKLY REALIZED WHAT OCCURRED AND REMOVED THE LOOP FROM THE PATIENT TISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25296516 ↗MalfunctionMay 20, 2026Device Remains Activated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING BREAST-CONSERVING SURGERY FOR BREAST CANCER, THE BUTTON ON THE DEVICE DID NOT RECOIL AUTOMATICALLY, CAUSING A SKIN BURN OF 1.0 CM X 1.0 CM ON THE PATIENT'S LEFT UPPER ARM. WHEN THE CONDITION WAS DISCOVERED, THE PENCIL WAS IMMEDIATELY DISCONTINUED AND THE CABLE WAS DISCONNECTED. THE AFFECTED AREA WAS WETTED AND THE PATIENT WAS DISINFECTED.
Patient problems: Burn(s)
MAUDE report 25230605 ↗MalfunctionMay 8, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, THE LOOP BECAME UNATTACHED FROM THE ELECTRODE. THE SURGEON RETRIEVED BROKEN PIECE AND NO LOOP WAS LEFT IN THE PATIENT. USED ANOTHER DEVICE AND CONTINUED THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25123405 ↗MalfunctionMay 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PROCEDURE, THE ELECTRODE THAT CAME ATTACHED WITH THE SMOKE PENCIL HAD BROKE IN HALF. THE BROKEN PIECE DID NOT FALL INTO THE PATIENT CAVITY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25068500 ↗MalfunctionApr 28, 2026Overheating of Device; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE CLOSING ON THE RIGHT BREAST INCISION SITE, THE INSULATED PORTION OF THE PENCIL TIP CONTACTED THE PATIENT'S SKIN AND CAUSED A SMALL BURN. THE PENCIL ITSELF WAS ALSO NOTED TO BE HOT TO THE TOUCH BY THE FA IN THE OR.
Patient problems: Burn(s)
MAUDE report 25017630 ↗MalfunctionApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A MINIMALLY INVASIVE CARDIAC SURGERY FOR MITRAL VALVE REPAIR, A PATIENT WAS BURNED ON HIS GENITAL AREA (PENIS) WITH VISIBLE BLISTERS. THE STAFF NOTICED THE BLISTERS ONCE THE CASE WAS COMPLETED AS IT WAS COVERED DURING THE PROCEDURE. THE PATIENT PLATE WAS PLACED ON THE BUTTOCK. ALCOHOL WAS WIPED AWAY FROM THE SITE WHERE THE PLATE WAS USED. THE PROCEDURE SETTINGS WERE 15 COAG AND 15 CUTTING. THE SURGEON WAS USING A COVIDIEN EDGE BUTTON SWITCH PENCIL SO HE WAS CHANGING THE ENERGY AS NEEDED FROM THE PENCIL.
Patient problems: Burn(s)
MAUDE report 24933621 ↗MalfunctionApr 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE PATIENT HAD FIRST DEGREE SKIN BURN AT THE THIGH WERE THE REM PAD WAS PLACED. NO TREATMENT WAS DONE TO THE BURN SITE.
Patient problems: Superficial (First Degree) Burn
MAUDE report 24872305 ↗
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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