Flexon 8886259143-2Recalls & reported problems

Covidien LP · Multifilament Temporary Cardiac Pacing Lead · Class 2

All models of Flexon (6)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 8
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521757554), received between Aug 18, 2023 and Sep 21, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).

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

Detachment of Device or Device Component8
Material Frayed4
Insufficient Device Problem Information3

Patient problems

Insufficient Information5
No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 21, 2023Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, POST-OPERATIVELY THE STRAIGHT METAL NEEDLE SEEMS TO BE BREAKING OFF THE INSULATED WIRE. IT WAS ALSO REPORTED THE DEVICE FRAY AND LEAVE LITTLE PARTICLES ON GLOVES. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17789158 ↗
MalfunctionSep 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE STRAIGHT METAL NEEDLE OF THE DEVICE SEEMS TO BE BREAKING OFF THE INSULATED WIRE. THEY ARE UNABLE TO PACE AT THE BEDSIDE.
Patient problems: Insufficient Information
MAUDE report 17721548 ↗
MalfunctionSep 8, 2023Material Frayed; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Frayed; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER POST-OPERATIVELY, THE CUSTOMER WAS COMPLAINING THAT THE STRAIGHT METAL NEEDLE OF THE DEVICE SEEMED TO BE BREAKING OFF THE INSULATED WIRE. THUS, THEY ARE UNABLE TO PACE AT THE BEDSIDE. A DEVICE SAMPLE WAS THEN TESTED POST-OPERATIVELY, SPUN THE WIRE OFF THE STRAIGHT NEEDLE AND IT CAME OFF. IT WAS ALSO REPORTED THAT THE DEVICE FRAY AND LEFT LITTLE PARTICLES ON HER GLOVES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17713463 ↗
MalfunctionSep 8, 2023Material Frayed; Detachment of Device or Device Component; Insufficient Device Problem Information; Material Frayed; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER POST-OPERATIVELY, THE CUSTOMER IS COMPLAINING THAT THE STRAIGHT METAL NEEDLE OF ALL 3 DEVICE SEEMS TO BE BREAKING OFF THE INSULATED WIRE. THUS, THEY ARE UNABLE TO PACE AT THE BEDSIDE. A DEVICE SAMPLE WAS THEN TESTED POST-OPERATIVELY, SPUN THE WIRE OFF THE STRAIGHT NEEDLE AND IT CAME OFF. IT WAS ALSO REPORTED THE DEVICE FRAY AND LEAVE LITTLE PARTICLES ON HER GLOVES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17713387 ↗
MalfunctionSep 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE WIRE BROKE OFF NEAR WHERE THE INSULATION WAS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17695171 ↗
MalfunctionSep 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE STRAIGHT METAL NEEDLE SEEMS TO BE BREAKING OFF THE INSULATED WIRE.
Patient problems: Insufficient Information
MAUDE report 17674301 ↗
MalfunctionAug 22, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE CUSTOMER IS COMPLAINING THAT THE STRAIGHT METAL NEEDLE SEEMS TO BE BREAKING OFF THE INSULATED WIRE. THUS, THEY ARE UNABLE TO PACE AT THE BEDSIDE.
Patient problems: Insufficient Information
MAUDE report 17600172 ↗
MalfunctionAug 18, 2023Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component
ACCORDING TO THE REPORTER POST-OPERATIVELY, THE CUSTOMER IS COMPLAINING THAT THE STRAIGHT METAL NEEDLE OF ALL 3 DEVICE SEEMS TO BE BREAKING OFF THE INSULATED WIRE. THUS, THEY ARE UNABLE TO PACE AT THE BEDSIDE. A DEVICE SAMPLE WAS THEN TESTED POST-OPERATIVELY, SPUN THE WIRE OFF THE STRAIGHT NEEDLE AND IT CAME OFF. IT WAS ALSO REPORTED THE DEVICE FRAY AND LEAVE LITTLE PARTICLES ON HER GLOVES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17577239 ↗

Device details

UDI-DI	`10884521757554`
Brand	Flexon
Model	8886259143-2
Company	Covidien LP
Product code	LDF · ELECTRODE, PACEMAKER, TEMPORARY
Class	Class 2
FDA submission	K955722
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jun 24, 2025

Device type (GMDN): Transthoracic pacing lead

A flexible wire with an electrode, insulated with non-conductive material except at its ends, that serves as an electrical conductor between the heart and an external temporary pacing/defibrillation device used to treat postoperative cardiac arrhythmias/cardiac arrests. The electrode end is attached to the myocardium. The other end initially is typically attached to a removable needle used to perforate the chest wall from the inside out, after which it is connected to a pulse generator, typically via an adaptor. This device is only used for temporary pacing of the heart and is removed once the patient is stable. This is a single-use device.

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All ELECTRODE, PACEMAKER, TEMPORARY 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 13, 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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