Multi-Link™ 2022948-002Recalls & reported problems

AirLife Finland Oy · Multi-Link™ ECG Care Cable, 3/5-lead with ESU filter, IEC, 3.6m / 12ft · 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 10889483576359), received between Dec 12, 2025 and Dec 12, 2025 — 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

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.

MalfunctionDec 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT DURING SURGERY, THE PATIENT'S HEART RATE REMAINED STABLE AT 60-80 BEATS PER MINUTE; HOWEVER, THE ELECTROCARDIOGRAM (ECG) MONITOR INTERMITTENTLY DISPLAYED VALUES AROUND 200 BPM. A SECONDARY VITAL SIGNS MONITOR WAS USED CONCURRENTLY, AND NO SAFETY ISSUES OCCURRED FOR THE PATIENT. THE ISSUE APPEARED TO BE RELATED TO A POOR CABLE CONNECTION NEAR THE ECG CONNECTOR ON THE DEVICE SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23792097 ↗

Device details

UDI-DI	`10889483576359`
Brand	Multi-Link™
Model	2022948-002
Company	AirLife Finland Oy
Product code	DSA · Cable, Transducer And Electrode, Patient, (Including Connector)
Class	Class 2
FDA submission	K980582
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Apr 7, 2025

Device type (GMDN): Electrocardiographic lead set, reusable

A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.