Multi-Link 412681-001Recalls & reported problems
Carefusion Finland 320 Oy · ECG Leadwire Grouped Set, 5-lead, Grabber, AHA, 74 cm/29 in · Class 2
- 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 10885403257049), received between Mar 22, 2021 and Mar 22, 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. How this data works · Data updated Oct 13, 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.
MalfunctionMar 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MULTI-LINK¿ ECG LEADWIRE, GROUPED SET, 5-LEAD, GRABBER, AHA, 74 CM/29 IN PROVIDED AN INCORRECT READING OF THE HEART RATE. IN THE MONITOR, THE HEART RATE WAS 30 TO 40 BEATS PER MINUTES, WHILE ON THE DOCTOR MANUAL CHECK OF THE HEART RATE IS AROUND 60 BEATS PER MINUTE. THERE WAS NO HARM NOTED AS THE MONITOR WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11544425 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.