FDA Device recall Z-1755-2023

CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1

FDA Device
Class I
ongoing
Published 2023-06-28

On 2023-06-28 the FDA classified a Class I recall of CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1 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

Agency	FDA Device
Recall number	Z-1755-2023
Classification	Class I
Status	ongoing
Initiated	2023-05-10
Published	2023-06-28
Last updated	2026-09-13 11:56 UTC
Company	Medtronic Cardiac Rhythm And Heart Failure Crhf
Distribution	US

Product

CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; 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 00643169837669, Lot Serial numbers: RPS205974H, RPS208665H, RPS206712H, RPS207744H, RPS205038H, RPS205791H, RPS20… GTIN 00643169837669, Lot Serial numbers: RPS205974H, RPS208665H, RPS206712H, RPS207744H, RPS205038H, RPS205791H, RPS206225H, RPS208216H, RPS206084H, RPS203804H, RPS208198H, RPS208245H, RPS205937H, RPS205565H, RPS206114H, RPS206723H, RPS206730H, RPS206733H, RPS206734H, RPS206754H, RPS207303H, RPS207318H, RPS207338H, RPS207399H, RPS207703H, RPS207711H, RPS207722H, RPS208049H, RPS208505H, RPS208646H, RPS208679H, RPS205303H, RPS205918H, RPS203315H, RPS204385H, RPS205650H, RPS202760H, RPS203013H, RPS203034H, RPS203256H, RPS203610H, RPS205372H, RPS206383H, RPS206771H, RPS207603H, RPS207933H, RPS208110H, RPS208492H, RPS204009H, RPS202981H, RPS207563H, RPS208546H, RPS202245H, RPS203960H, RPS204342H, RPS204357H, RPS205958H, RPS207822H, RPS207840H, RPS207922H, RPS207923H, RPS207984H, RPS208255H, RPS208529H, RPS208575H, RPS208590H, RPS208615H, RPS203563H, RPS206128H, RPS206413H, RPS206762H, RPS207904H, RPS208608H, RPS202171H, RPS202841H, RPS202860H, RPS203565H, RPS204198H, RPS202792H, RPS202793H

code_info

GTIN 00643169837669, Lot Serial numbers: RPS205974H, RPS208665H, RPS206712H, RPS207744H, RPS205038H, RPS205791H, RPS20…

GTIN 00643169837669, Lot Serial numbers: RPS205974H, RPS208665H, RPS206712H, RPS207744H, RPS205038H, RPS205791H, RPS206225H, RPS208216H, RPS206084H, RPS203804H, RPS208198H, RPS208245H, RPS205937H, RPS205565H, RPS206114H, RPS206723H, RPS206730H, RPS206733H, RPS206734H, RPS206754H, RPS207303H, RPS207318H, RPS207338H, RPS207399H, RPS207703H, RPS207711H, RPS207722H, RPS208049H, RPS208505H, RPS208646H, RPS208679H, RPS205303H, RPS205918H, RPS203315H, RPS204385H, RPS205650H, RPS202760H, RPS203013H, RPS203034H, RPS203256H, RPS203610H, RPS205372H, RPS206383H, RPS206771H, RPS207603H, RPS207933H, RPS208110H, RPS208492H, RPS204009H, RPS202981H, RPS207563H, RPS208546H, RPS202245H, RPS203960H, RPS204342H, RPS204357H, RPS205958H, RPS207822H, RPS207840H, RPS207922H, RPS207923H, RPS207984H, RPS208255H, RPS208529H, RPS208575H, RPS208590H, RPS208615H, RPS203563H, RPS206128H, RPS206413H, RPS206762H, RPS207904H, RPS208608H, RPS202171H, RPS202841H, RPS202860H, RPS203565H, RPS204198H, RPS202792H, RPS202793H

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-1755-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.