Home / Recalls / Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) / Z-1801-2023

Z-1801-2023 Class I Ongoing

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

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
21 units

Product Description

ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; 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 00763000115647, Lot Serial Numbers: EVR600484S, EVR600487S, EVR600488S, EVR600489S, EVR600490S, EVR600492S, EVR600494S, EVR600479S, EVR600480S, EVR600483S, EVR600500S, EVR600495S, EVR600496S, EVR600478S, EVR600516S, EVR600517S, EVR600519S, EVR600521S, EVR600522S, EVR600525S, EVR600526S

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

  • Z-1707-2023 Class I — ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardiov (May 10, 2023)
  • Z-1759-2023 Class I — CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardiov (May 10, 2023)
  • Z-1718-2023 Class I — ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibr (May 10, 2023)
  • Z-1797-2023 Class I — ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardiov (May 10, 2023)
  • Z-1717-2023 Class I — ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibr (May 10, 2023)
  • Z-1796-2023 Class I — ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter (May 10, 2023)
  • Z-1782-2023 Class I — CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defi (May 10, 2023)
  • Z-1815-2023 Class I — ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibr (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-1766-2023 Class I — CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter (May 10, 2023)