FDA Device recall Z-1756-2023

CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ

FDA Device
Class I
ongoing
Published 2023-06-28

On 2023-06-28 the FDA classified a Class I recall of CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ 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-1756-2023
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 DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; 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 CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Lot Serial Numbers: RPA210493H, RPA222265H, RPA231080H, RPA238029H, RPA22016… GTIN CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Lot Serial Numbers: RPA210493H, RPA222265H, RPA231080H, RPA238029H, RPA220160H, RPA224981H, RPA226922H, RPA226926H, RPA226931H, RPA226935H, RPA226936H, RPA231700H, RPA231701H, RPA231707H, RPA231708H, RPA231711H, RPA235632H, RPA235645H, RPA235649H, RPA240455H, RPA240473H, RPA240476H, RPA240477H, RPA214967H, RPA219025H, RPA220582H, RPA224560H, RPA229904H, RPA230197H, RPA232865H, RPA239124H, RPA240812H, RPA240813H, RPA240814H, RPA240817H, RPA240821H, RPA240822H, RPA240825H, RPA240831H, RPA240834H, RPA240838H, RPA220840H, RPA225194H, RPA233160H, RPA242772H, RPA222022H, RPA222334H, RPA226679H, RPA228141H, RPA228927H, RPA229342H, RPA229425H, RPA240558H, RPA241482H, RPA242003H, RPA242887H, RPA240059H, RPA240830H, RPA242610H, RPA242611H, RPA242695H, RPA242800H, RPA243342H, RPA243356H, RPA243358H, RPA232874H, RPA240168H, RPA208767H, RPA208769H, RPA211496H, RPA212326H, RPA213403H, RPA213430H, RPA215858H, RPA215861H, RPA215864H, RPA222904H, RPA222906H, R

code_info

GTIN CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Lot Serial Numbers: RPA210493H, RPA222265H, RPA231080H, RPA238029H, RPA22016…

GTIN CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Lot Serial Numbers: RPA210493H, RPA222265H, RPA231080H, RPA238029H, RPA220160H, RPA224981H, RPA226922H, RPA226926H, RPA226931H, RPA226935H, RPA226936H, RPA231700H, RPA231701H, RPA231707H, RPA231708H, RPA231711H, RPA235632H, RPA235645H, RPA235649H, RPA240455H, RPA240473H, RPA240476H, RPA240477H, RPA214967H, RPA219025H, RPA220582H, RPA224560H, RPA229904H, RPA230197H, RPA232865H, RPA239124H, RPA240812H, RPA240813H, RPA240814H, RPA240817H, RPA240821H, RPA240822H, RPA240825H, RPA240831H, RPA240834H, RPA240838H, RPA220840H, RPA225194H, RPA233160H, RPA242772H, RPA222022H, RPA222334H, RPA226679H, RPA228141H, RPA228927H, RPA229342H, RPA229425H, RPA240558H, RPA241482H, RPA242003H, RPA242887H, RPA240059H, RPA240830H, RPA242610H, RPA242611H, RPA242695H, RPA242800H, RPA243342H, RPA243356H, RPA243358H, RPA232874H, RPA240168H, RPA208767H, RPA208769H, RPA211496H, RPA212326H, RPA213403H, RPA213430H, RPA215858H, RPA215861H, RPA215864H, RPA222904H, RPA222906H, R

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-1756-2023%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.