Valleylab E3520HRecalls & reported problems
Covidien LP · Argon Handset · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521782570), received between Apr 21, 2022 and Mar 5, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
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
- Adverse Event Without Identified Device or Use Problem2
- Device Alarm System1
- Inappropriate/Inadequate Shock/Stimulation1
- Melted1
- Overheating of Device1
Patient problems
- Burn(s)2
- Electric Shock1
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE MACHINE WAS BEING USED WITH A FORCETRIAD. NURSE RECEIVED AN ELECTRIC SHOCK AND BURN AT FRONT OF FORCETRIAD IN USE WITH A FORCE ARGON.
Patient problems: Burn(s); Electric Shock
MAUDE report 18842672 ↗MalfunctionSep 1, 2022Device Alarm System; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD AN ERROR CODE 94-GAS OCCLUSION. THE PATIENT HAD BLEEDING OF LESS THAN 250CC. BLOOD TRANSFUSION WAS NOT REQUIRED. A NEW DEVICE WAS OPENED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 15339492 ↗MalfunctionApr 21, 2022Melted; Overheating of Device; Melted; Overheating of Device
ACCORDING TO THE REPORTER, DURING PNEUMONECTOMY WITH HEATED CHEMOTHERAPY, THE DEVICE OVERHEATED AND MELTED DURING THE PROCEDURE AND BURNT THE PATIENT. THE PATIENT HAD SEVERAL SMALL BURNS ON THE CHEST.
Patient problems: Burn(s)
MAUDE report 14165052 ↗
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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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