FDA Device recall Z-1769-2023

CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1

FDA Device
Class I
ongoing
Published 2023-06-28

On 2023-06-28 the FDA classified a Class I recall of CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1 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-1769-2023
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 DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; 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 00643169837706, Lot Serial Numbers: RPW200770H, RPW200730H, RPW201054H, RPW200583H, RPW200593H, RPW200970H, RPW20… GTIN 00643169837706, Lot Serial Numbers: RPW200770H, RPW200730H, RPW201054H, RPW200583H, RPW200593H, RPW200970H, RPW201002H, RPW201095H, RPW200917H, RPW201040H, RPW201026H, RPW200661H, RPW200981H, RPW200665H, RPW200741H, RPW200743H, RPW200908H, RPW200971H, RPW200600H, RPW200635H, RPW200638H, RPW200652H, RPW200657H, RPW200660H, RPW200761H, RPW200800H, RPW200803H, RPW200822H, RPW200827H, RPW200714H, RPW200809H, RPW200548H, RPW201023H, RPW201103H, RPW200575H, RPW200794H, RPW200807H, RPW200994H, RPW201055H, RPW200630H, RPW200659H, RPW200904H, RPW201079H, RPW201171H, RPW200578H, RPW200695H, RPW200621H, RPW201015H, RPW201084H, RPW201151H, RPW201153H, RPW200590H, RPW200938H, RPW200582H, RPW200847H, RPW200870H, RPW200683H, RPW200685H, RPW200754H, RPW200852H, RPW200585H, RPW200648H, RPW200669H, RPW200673H, RPW200721H, RPW200839H, RPW200879H, RPW200882H, RPW201041H, RPW201140H, RPW201161H, RPW200692H, RPW200863H, RPW200881H, RPW200969H, RPW201032H, RPW200553H, RPW200543H, RPW200595H, RPW200686H

code_info

GTIN 00643169837706, Lot Serial Numbers: RPW200770H, RPW200730H, RPW201054H, RPW200583H, RPW200593H, RPW200970H, RPW20…

GTIN 00643169837706, Lot Serial Numbers: RPW200770H, RPW200730H, RPW201054H, RPW200583H, RPW200593H, RPW200970H, RPW201002H, RPW201095H, RPW200917H, RPW201040H, RPW201026H, RPW200661H, RPW200981H, RPW200665H, RPW200741H, RPW200743H, RPW200908H, RPW200971H, RPW200600H, RPW200635H, RPW200638H, RPW200652H, RPW200657H, RPW200660H, RPW200761H, RPW200800H, RPW200803H, RPW200822H, RPW200827H, RPW200714H, RPW200809H, RPW200548H, RPW201023H, RPW201103H, RPW200575H, RPW200794H, RPW200807H, RPW200994H, RPW201055H, RPW200630H, RPW200659H, RPW200904H, RPW201079H, RPW201171H, RPW200578H, RPW200695H, RPW200621H, RPW201015H, RPW201084H, RPW201151H, RPW201153H, RPW200590H, RPW200938H, RPW200582H, RPW200847H, RPW200870H, RPW200683H, RPW200685H, RPW200754H, RPW200852H, RPW200585H, RPW200648H, RPW200669H, RPW200673H, RPW200721H, RPW200839H, RPW200879H, RPW200882H, RPW201041H, RPW201140H, RPW201161H, RPW200692H, RPW200863H, RPW200881H, RPW200969H, RPW201032H, RPW200553H, RPW200543H, RPW200595H, RPW200686H

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-1769-2023%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.