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

FDA device recall Z-0282-2022 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on October 12, 2021 and is designated Class II. Reason for recall: The processing of collected episode data may fail due to a software error. The recall status is ongoing. Affected quantity: 18,715 devices.

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-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)