Valleylab E1650Recalls & reported problems
Covidien LP · Straight Micro-Needle Electrode · Class 2
All models of Valleylab (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521713345), received between Apr 12, 2022 and Nov 2, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Melted1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Superficial (First Degree) Burn1
- Unintended Radiation Exposure1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING MELANOMA REMOVAL ON NECK, THE TIP OF THE DEVICE COMPLETELY BROKE OFF. X-RAY WAS PERFORMED TO LOCATE THE BROKEN PIECE BUT IT COULD NOT BE FOUND.
Patient problems: Unintended Radiation Exposure
MAUDE report 18054042 ↗MalfunctionApr 21, 2022Melted; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem; Melted; Peeled/Delaminated; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING BLEPHAROPLASTY, THE ELECTRODE'S INSULATION MELTED. IT CAUSED A FIRST DEGREE BURN ON THE EXCESS TISSUE OF THE EYELID WHICH WAS BEING REMOVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn
MAUDE report 14174358 ↗MalfunctionApr 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE MELTED AND BURNED ON EYELID, BUT FORTUNATELY IT WAS ON TISSUE BEING REMOVED, 1ST DEGREE BURN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14090624 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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