MEDLINE 401970RHRecalls & reported problems

Medline Industries, Inc. · SJM CATH CABLE 2 4POLE BLK RESPONSE150CM · 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 10193489189841), received between Aug 13, 2026 and Aug 13, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Conduct” (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

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

Most reported problems

Device problems

Failure to Conduct1
No Pacing1

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.

MalfunctionAug 13, 2026Failure to Conduct; No Pacing
It was reported that the cable failed. Unable to pace with this cable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235366 ↗

Device details

UDI-DI	`10193489189841`
Brand	MEDLINE
Model	401970RH
Company	Medline Industries, Inc.
Product code	IKD · CABLE, ELECTRODE
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 21, 2025

Device type (GMDN): Electrical-only medical device connection cable, reprocessed

A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a single-use device previously used that has been reprocessed for an additional single-use patient application.

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All CABLE, ELECTRODE devices →

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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