FDA Device recall Z-1761-2023

CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1

FDA Device
Class I
ongoing
Published 2023-06-28

On 2023-06-28 the FDA classified a Class I recall of CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1 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-1761-2023
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 DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; 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 00643169837690, Lot Serial Numbers: RPV203851H, RPV203879H, RPV204192H, RPV204308H, RPV205279H, RPV205423H, RPV20… GTIN 00643169837690, Lot Serial Numbers: RPV203851H, RPV203879H, RPV204192H, RPV204308H, RPV205279H, RPV205423H, RPV205665H, RPV205443H, RPV205510H, RPV204476H, RPV205107H, RPV204152H, RPV204326H, RPV204327H, RPV204329H, RPV203937H, RPV204831H, RPV204911H, RPV205343H, RPV205351H, RPV205497H, RPV205762H, RPV205763H, RPV205785H, RPV203840H, RPV204908H, RPV205661H, RPV203773H, RPV203795H, RPV203808H, RPV204568H, RPV205383H, RPV205713H, RPV205312H, RPV205849H, RPV204239H, RPV205251H, RPV203909H, RPV204821H, RPV205370H, RPV205812H, RPV205832H, RPV205093H, RPV204730H, RPV204741H, RPV204553H, RPV203983H, RPV205414H, RPV205597H, RPV205682H, RPV205541H, RPV204597H, RPV204711H, RPV205219H, RPV205645H, RPV205215H, RPV205056H, RPV203988H, RPV204130H, RPV204198H, RPV204610H, RPV205672H, RPV205843H, RPV205358H, RPV205484H, RPV205614H, RPV204042H, RPV204393H, RPV204418H, RPV204768H, RPV205338H, RPV205636H, RPV204270H, RPV205806H, RPV204735H, RPV204785H, RPV204806H, RPV205115H, RPV205117H, RPV205118H

code_info

GTIN 00643169837690, Lot Serial Numbers: RPV203851H, RPV203879H, RPV204192H, RPV204308H, RPV205279H, RPV205423H, RPV20…

GTIN 00643169837690, Lot Serial Numbers: RPV203851H, RPV203879H, RPV204192H, RPV204308H, RPV205279H, RPV205423H, RPV205665H, RPV205443H, RPV205510H, RPV204476H, RPV205107H, RPV204152H, RPV204326H, RPV204327H, RPV204329H, RPV203937H, RPV204831H, RPV204911H, RPV205343H, RPV205351H, RPV205497H, RPV205762H, RPV205763H, RPV205785H, RPV203840H, RPV204908H, RPV205661H, RPV203773H, RPV203795H, RPV203808H, RPV204568H, RPV205383H, RPV205713H, RPV205312H, RPV205849H, RPV204239H, RPV205251H, RPV203909H, RPV204821H, RPV205370H, RPV205812H, RPV205832H, RPV205093H, RPV204730H, RPV204741H, RPV204553H, RPV203983H, RPV205414H, RPV205597H, RPV205682H, RPV205541H, RPV204597H, RPV204711H, RPV205219H, RPV205645H, RPV205215H, RPV205056H, RPV203988H, RPV204130H, RPV204198H, RPV204610H, RPV205672H, RPV205843H, RPV205358H, RPV205484H, RPV205614H, RPV204042H, RPV204393H, RPV204418H, RPV204768H, RPV205338H, RPV205636H, RPV204270H, RPV205806H, RPV204735H, RPV204785H, RPV204806H, RPV205115H, RPV205117H, RPV205118H

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-1761-2023%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.