Home / Recalls / Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) / Z-1480-2022

Z-1480-2022 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
August 3, 2022
Initiation Date
November 5, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

Reason for Recall

Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.

Distribution Pattern

US Nationwide distribution in the states of Indiana and CA.

Code Information

GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S

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)