Home / Recalls / Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) / Z-1743-2023

Z-1743-2023 Class I Ongoing

Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) — Mounds View, MN

FDA device recall Z-1743-2023 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on May 10, 2023 and is designated Class I. Reason for recall: 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 de… The recall status is ongoing.

Recall Details

Product Type: Devices
Report Date: June 28, 2023
Initiation Date: May 10, 2023
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

Product Description

CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators

Reason for Recall

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.

Distribution Pattern

US Nationwide - Worldwide Distribution

Code Information

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, BLM202914H, BLM203002H, BLM202833H, BLM202983H, BLM202985H, BLM202986H, BLM202987H, BLM202988H, BLM202992H, BLM202996H, BLM203003H, BLM203005H, BLM203008H, BLM203016H, BLM203022H, BLM203043H, BLM203046H, BLM203047H, BLM203048H, BLM203049H, BLM203066H, BLM202851H, BLM202852H, BLM202866H, BLM202875H, BLM202984H, BLM203026H, BLM203054H, BLM202860H, BLM202927H, BLM202846H, BLM202943H, BLM202951H, BLM202989H, BLM202876H, BLM202825H, BLM202915H, BLM202954H, BLM202849H, BLM202836H, BLM203053H, BLM203064H, BLM203067H

Other recalls by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Z-1805-2023 Class I — ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardi (May 10, 2023)
Z-1782-2023 Class I — CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defi (May 10, 2023)
Z-1771-2023 Class I — CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter (May 10, 2023)
Z-1812-2023 Class I — ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardio (May 10, 2023)
Z-1804-2023 Class I — ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardiover (May 10, 2023)
Z-1735-2023 Class I — CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardiover (May 10, 2023)
Z-1760-2023 Class I — CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardiov (May 10, 2023)
Z-1766-2023 Class I — CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter (May 10, 2023)
Z-1724-2023 Class I — ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Card (May 10, 2023)
Z-1718-2023 Class I — ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibr (May 10, 2023)