N/A 403751-009Recalls & reported problems
Carefusion Finland 320 Oy · ECG Leadwire, DIN, Radiolucent 5-lead, Grabber, AHA, 150 cm/59 in · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403256936), received between Apr 5, 2021 and Apr 5, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE EKG SIGNAL OF ECG LEADWIRE, DIN, RADIOLUCENT, 5-LEAD, GRABBER, AHA, 150 CM/59 IN IS VERY FUZZY. THE LEAD 2 SHOW ARTIFACT, TACHYCARDIA AND UNCLEAR EKG RHYTHM EVEN IF THE PATIENT IS NOT MOVING . AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11614729 ↗
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- CORE M2 Vascular System 400-0100.17Volcano Corporation · Cable, Transducer And Electrode, Patient, (Including Connector)6 reports
- NA 5487Medtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)6 reports
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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