Home / Recalls / Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) / Z-0282-2022

Z-0282-2022 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
December 1, 2021
Initiation Date
October 12, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18,715 devices

Product Description

Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DPA2D4; Cobalt DR: DDPB3D1, DDPB3D4; Cobalt XT HF: DTPA2D4, DTPA2D1; Cobalt XT HF; Quad: DTPA2QQ, DTPA2Q1; Cobalt HF: DTPB2D4, DTPB2D1; Cobalt HF Quad: DTPB2QQ, DTPB2Q1. Crome VR: DVPC3D1, DVPC3D4; Crome DR: DDPC3D1, DDPC3D4; Crome HF: DTPC2D4, DTPC2D1; Crome HF Quad: DTPC2QQ, DTPC2Q1.

Reason for Recall

The processing of collected episode data may fail due to a software error.

Distribution Pattern

Worldwide distribution - US Nationwide. There was military/government distribution. The countries of Andorra, Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Liechtenstein, Luxembourg, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Code Information

Application software lower than v5.0.0.

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)