Medline MDSLWP509Recalls & reported problems

Medline Industries, Inc. · LEADWIRE, DISP, 5-LEAD, PINCH, GE MULTI · 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 10888277697638), received between Sep 24, 2026 and Sep 24, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Misconnection” (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

Misconnection1

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.

MalfunctionSep 24, 2026Misconnection
It was reported that DSLWP509 was incorrectly connected to the trunk cable (i.e., plugged in upside down), the reading produced HR 0 and Asystole on the monitor. While the ICU staff tested Medline branded leadwires, this false Asystole reading occurred twice in less than 24 hours.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884318 ↗

Device details

UDI-DI	`10888277697638`
Brand	Medline
Model	MDSLWP509
Company	Medline Industries, Inc.
Product code	DSA · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Sep 29, 2023

Device type (GMDN): Electrocardiographic electrode, single-use

A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use 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.