Home / Recalls / Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) / Z-0928-2021

Z-0928-2021 Class II Terminated

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

FDA device recall Z-0928-2021 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on November 15, 2020 and is designated Class II. Reason for recall: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. The recall status is terminated (terminated December 23, 2025). Affected quantity: 2 units.

Recall Details

Product Type
Devices
Report Date
February 3, 2021
Initiation Date
November 15, 2020
Termination Date
December 23, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)

Reason for Recall

Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

Distribution Pattern

Distribution to US states of GA, PA, NJ, and France

Code Information

Serial Numbers: RSN600251S, RSN600656S

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)

FDA data resources