FDA Device recall Z-1754-2023

CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4

FDA Device
Class I
ongoing
Published 2023-06-28

On 2023-06-28 the FDA classified a Class I recall of CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4 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-1754-2023
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 DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; 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 00643169720657, Lot Serial Numbers: RPC203306H, RPC205335H, RPC207546H, RPC210227H, RPC205865H, RPC205916H, RPC20… GTIN 00643169720657, Lot Serial Numbers: RPC203306H, RPC205335H, RPC207546H, RPC210227H, RPC205865H, RPC205916H, RPC205937H, RPC206296H, RPC206416H, RPC206665H, RPC207309H, RPC207864H, RPC208393H, RPC209253H, RPC209691H, RPC209707H, RPC209745H, RPC209762H, RPC209847H, RPC209918H, RPC209843H, RPC203399H, RPC204295H, RPC202725H, RPC207338H, RPC204122H, RPC210083H, RPC207179H, RPC207493H, RPC207715H, RPC208839H, RPC210208H, RPC210209H, RPC210279H, RPC202502H, RPC206685H, RPC207835H, RPC202337H, RPC203913H, RPC206604H, RPC206605H, RPC206608H, RPC206609H, RPC207319H, RPC207608H, RPC209946H, RPC207476H, RPC208004H, RPC205236H, RPC207257H, RPC202491H, RPC202610H, RPC203628H, RPC203989H, RPC204238H, RPC204412H, RPC204523H, RPC205585H, RPC210162H, RPC202353H, RPC202434H, RPC202549H, RPC202947H, RPC203116H, RPC207575H, RPC202513H, RPC205862H, RPC207849H, RPC209388H, RPC210124H, RPC203780H, RPC204065H, RPC204066H, RPC210111H, RPC204504H, RPC203114H, RPC205516H, RPC205847H, RPC207025H, RPC207175H

code_info

GTIN 00643169720657, Lot Serial Numbers: RPC203306H, RPC205335H, RPC207546H, RPC210227H, RPC205865H, RPC205916H, RPC20…

GTIN 00643169720657, Lot Serial Numbers: RPC203306H, RPC205335H, RPC207546H, RPC210227H, RPC205865H, RPC205916H, RPC205937H, RPC206296H, RPC206416H, RPC206665H, RPC207309H, RPC207864H, RPC208393H, RPC209253H, RPC209691H, RPC209707H, RPC209745H, RPC209762H, RPC209847H, RPC209918H, RPC209843H, RPC203399H, RPC204295H, RPC202725H, RPC207338H, RPC204122H, RPC210083H, RPC207179H, RPC207493H, RPC207715H, RPC208839H, RPC210208H, RPC210209H, RPC210279H, RPC202502H, RPC206685H, RPC207835H, RPC202337H, RPC203913H, RPC206604H, RPC206605H, RPC206608H, RPC206609H, RPC207319H, RPC207608H, RPC209946H, RPC207476H, RPC208004H, RPC205236H, RPC207257H, RPC202491H, RPC202610H, RPC203628H, RPC203989H, RPC204238H, RPC204412H, RPC204523H, RPC205585H, RPC210162H, RPC202353H, RPC202434H, RPC202549H, RPC202947H, RPC203116H, RPC207575H, RPC202513H, RPC205862H, RPC207849H, RPC209388H, RPC210124H, RPC203780H, RPC204065H, RPC204066H, RPC210111H, RPC204504H, RPC203114H, RPC205516H, RPC205847H, RPC207025H, RPC207175H

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-1754-2023%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.