Cyberonics® Patient Magnet 220Recalls & reported problems

Livanova USA, Inc. · Patient Magnet · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05425025750252), received between Apr 11, 2018 and Apr 11, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Circuit Failure” (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 18, 2026.

Most reported problems

Device problems

Circuit Failure1

Patient problems

Burning Sensation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryApr 11, 2018Circuit Failure
CYBERONICS VNS MAGNET MODEL 220 IMPLANT ON (B)(6) 2016. (B)(6) 2016 DEVICE SHORT CIRCUITED CAUSING POTENTIAL DAMAGE TO VAGAL NERVE. PATIENT FELT EXTREME HEAT AND COULD NOT MOVE FOR 24 HOURS. DEVICE THEN SHUT OFF, HAD TO BE SURGICALLY REMOVED AND REPLACED ON (B)(6) 2016. PICTURE OF MALFUNCTION DEVICE SHOWS BUBBLE THAT FORMED TO INTERFERE WITH WIRES. DEVICE SENT BACK TO CYBERONICS. LOT NUMBER 1464006.
Patient problems: Burning Sensation
MAUDE report 7424951 ↗

Device details

UDI-DI	`05425025750252`
Brand	Cyberonics® Patient Magnet
Model	220
Company	Livanova USA, Inc.
Product code	DTG · Magnet, Test, Pacemaker
Class	Class 1
FDA submission	K092364
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 22, 2021

Device type (GMDN): Active implantable device control magnet

A hand-operated, non-sterile, magnetic device designed to be used by a patient and a healthcare professional to switch an active implantable device (e.g., pulse generator, implantable cardiac monitor) on and off. It typically consists of a small portable magnet (e.g., strontium ferrite) coated with an epoxy that can be carried in the pocket or a handbag (purse) of a patient for convenient access. It is placed by the patient against the skin directly over the site of the implant and turned as prescribed by the manufacturer. This is a reusable device.

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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