FDA Device recall Z-1743-2023

CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1

FDA Device
Class I
ongoing
Published 2023-06-28

On 2023-06-28 the FDA classified a Class I recall of CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1 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-1743-2023
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

CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; 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 00643169720206, Lot Serial Numbers: BLM202912H, BLM203000H, BLM202895H, BLM202965H, BLM203007H, BLM203028H, BLM20… GTIN 00643169720206, Lot Serial Numbers: BLM202912H, BLM203000H, BLM202895H, BLM202965H, BLM203007H, BLM203028H, BLM203031H, BLM203063H, BLM202844H, BLM202900H, BLM203042H, BLM203014H, BLM203015H, BLM203062H, BLM202811H, BLM202838H, BLM202857H, BLM202858H, BLM202881H, BLM202923H, BLM203001H, BLM203021H, BLM202848H, BLM202878H, BLM202827H, BLM202952H, BLM203061H, BLM202909H, BLM202921H, BLM202942H, BLM202830H, BLM202850H, BLM202886H, BLM202888H, BLM202829H, BLM202911H, BLM202958H, BLM202982H, BLM203037H, BLM202945H, BLM202929H, BLM202949H, BLM202973H, BLM202828H, BLM202990H, BLM202947H, BLM202960H, BLM202854H, BLM202944H, BLM202810H, BLM202847H, BLM202862H, BLM202880H, BLM202904H, BLM202946H, BLM202974H, BLM202979H, BLM203006H, BLM203012H, BLM203040H, BLM202932H, BLM202913H, BLM202940H, BLM202842H, BLM202980H, BLM203029H, BLM203058H, BLM203065H, BLM202972H, BLM203051H, BLM202867H, BLM202948H, BLM203004H, BLM202832H, BLM202999H, BLM202885H, BLM202976H, BLM203035H, BLM203009H, BLM203024H

code_info

GTIN 00643169720206, Lot Serial Numbers: BLM202912H, BLM203000H, BLM202895H, BLM202965H, BLM203007H, BLM203028H, BLM20…

GTIN 00643169720206, Lot Serial Numbers: BLM202912H, BLM203000H, BLM202895H, BLM202965H, BLM203007H, BLM203028H, BLM203031H, BLM203063H, BLM202844H, BLM202900H, BLM203042H, BLM203014H, BLM203015H, BLM203062H, BLM202811H, BLM202838H, BLM202857H, BLM202858H, BLM202881H, BLM202923H, BLM203001H, BLM203021H, BLM202848H, BLM202878H, BLM202827H, BLM202952H, BLM203061H, BLM202909H, BLM202921H, BLM202942H, BLM202830H, BLM202850H, BLM202886H, BLM202888H, BLM202829H, BLM202911H, BLM202958H, BLM202982H, BLM203037H, BLM202945H, BLM202929H, BLM202949H, BLM202973H, BLM202828H, BLM202990H, BLM202947H, BLM202960H, BLM202854H, BLM202944H, BLM202810H, BLM202847H, BLM202862H, BLM202880H, BLM202904H, BLM202946H, BLM202974H, BLM202979H, BLM203006H, BLM203012H, BLM203040H, BLM202932H, BLM202913H, BLM202940H, BLM202842H, BLM202980H, BLM203029H, BLM203058H, BLM203065H, BLM202972H, BLM203051H, BLM202867H, BLM202948H, BLM203004H, BLM202832H, BLM202999H, BLM202885H, BLM202976H, BLM203035H, BLM203009H, BLM203024H

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-1743-2023%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.