RecallRadar

FDA Device recall Z-1753-2023

CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1

On 2023-06-28 the FDA classified a Class I recall of CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1 by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing there is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynch….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1753-2023
ClassificationClass I
Statusongoing
Initiated2023-05-10
Published2023-06-28
Last updated2026-09-13 11:56 UTC
CompanyMedtronic Cardiac Rhythm And Heart Failure Crhf
DistributionUS

Product

CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators

Reason

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Identifiers

code_info
GTIN 00643169837676, Lot Serial Numbers: RPT208454H, RPT211000H, RPT208258H, RPT211071H, RPT211077H, RPT210886H, RPT20…GTIN 00643169837676, Lot Serial Numbers: RPT208454H, RPT211000H, RPT208258H, RPT211071H, RPT211077H, RPT210886H, RPT209224H, RPT211338H, RPT211343H, RPT211344H, RPT211347H, RPT208864H, RPT210392H, RPT204063H, RPT207540H, RPT210779H, RPT211477H, RPT210662H, RPT203810H, RPT204233H, RPT210695H, RPT204352H, RPT204713H, RPT205727H, RPT208222H, RPT208507H, RPT210829H, RPT211217H, RPT206139H, RPT207062H, RPT210688H, RPT210917H, RPT203993H, RPT205235H, RPT205768H, RPT206518H, RPT206833H, RPT209343H, RPT209843H, RPT205560H, RPT206519H, RPT210915H, RPT210978H, RPT207320H, RPT204196H, RPT205788H, RPT207588H, RPT209206H, RPT209796H, RPT210253H, RPT210444H, RPT210700H, RPT211542H, RPT211685H, RPT205575H, RPT205841H, RPT207926H, RPT204420H, RPT205180H, RPT204120H, RPT204133H, RPT209974H, RPT205340H, RPT209909H, RPT210452H, RPT211124H, RPT203859H, RPT205468H, RPT208257H, RPT208621H, RPT209674H, RPT211043H, RPT210842H, RPT211476H, RPT207094H, RPT208370H, RPT206004H, RPT206049H, RPT210092H, RPT210217H

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1753-2023%22

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