FDA Device recall Z-1767-2023

CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1

FDA Device
Class I
ongoing
Published 2023-06-28

On 2023-06-28 the FDA classified a Class I recall of CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1 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-1767-2023
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 DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; 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 00643169837638, Lot Serial Numbers: RPP602125S, RPP602593S, RPP603699S, RPP602902S, RPP602417S, RPP601873S, RPP60… GTIN 00643169837638, Lot Serial Numbers: RPP602125S, RPP602593S, RPP603699S, RPP602902S, RPP602417S, RPP601873S, RPP602956S, RPP601533S, RPP603620S, RPP600808S, RPP603725S, RPP602431S, RPP602451S, RPP602452S, RPP602460S, RPP602737S, RPP602741S, RPP602778S, RPP602780S, RPP603298S, RPP603299S, RPP603300S, RPP603303S, RPP603679S, RPP603685S, RPP603686S, RPP603690S, RPP603812S, RPP603814S, RPP603815S, RPP603819S, RPP603821S, RPP603822S, RPP603825S, RPP603832S, RPP603833S, RPP603840S, RPP603843S, RPP603844S, RPP603847S, RPP603848S, RPP603849S, RPP603852S, RPP603855S, RPP603859S, RPP603860S, RPP603861S, RPP603862S, RPP603863S, RPP603868S, RPP603870S, RPP603871S, RPP602254S, RPP603326S, RPP601331S, RPP601392S, RPP602961S, RPP601050S, RPP602800S, RPP603221S, RPP602233S, RPP603560S, RPP603768S, RPP603806S, RPP600598S, RPP602145S, RPP602648S, RPP602799S, RPP603486S, RPP603323S, RPP600640S, RPP602076S, RPP602927S, RPP602720S, RPP602731S, RPP602825S, RPP603224S, RPP603469S, RPP603540S, RPP603121S

code_info

GTIN 00643169837638, Lot Serial Numbers: RPP602125S, RPP602593S, RPP603699S, RPP602902S, RPP602417S, RPP601873S, RPP60…

GTIN 00643169837638, Lot Serial Numbers: RPP602125S, RPP602593S, RPP603699S, RPP602902S, RPP602417S, RPP601873S, RPP602956S, RPP601533S, RPP603620S, RPP600808S, RPP603725S, RPP602431S, RPP602451S, RPP602452S, RPP602460S, RPP602737S, RPP602741S, RPP602778S, RPP602780S, RPP603298S, RPP603299S, RPP603300S, RPP603303S, RPP603679S, RPP603685S, RPP603686S, RPP603690S, RPP603812S, RPP603814S, RPP603815S, RPP603819S, RPP603821S, RPP603822S, RPP603825S, RPP603832S, RPP603833S, RPP603840S, RPP603843S, RPP603844S, RPP603847S, RPP603848S, RPP603849S, RPP603852S, RPP603855S, RPP603859S, RPP603860S, RPP603861S, RPP603862S, RPP603863S, RPP603868S, RPP603870S, RPP603871S, RPP602254S, RPP603326S, RPP601331S, RPP601392S, RPP602961S, RPP601050S, RPP602800S, RPP603221S, RPP602233S, RPP603560S, RPP603768S, RPP603806S, RPP600598S, RPP602145S, RPP602648S, RPP602799S, RPP603486S, RPP603323S, RPP600640S, RPP602076S, RPP602927S, RPP602720S, RPP602731S, RPP602825S, RPP603224S, RPP603469S, RPP603540S, RPP603121S

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-1767-2023%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.