Crome and Cobalt MRI Surescan
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Crome Hf Quad Crt-D Mri Surescan | All lots. | DTPC2QQ DTPC2Q1 |
| Crome Hf Crt-D Mri Surescan | All lots. | DTPC2D4 DTPC2D1 |
| Crome Vr Mri Surescan | All lots. | DVPC3D4 DVPC3D1 |
| Cobalt Hf Crt-D Mri Surescan | All lots. | DTPB2D1 DTPB2D4 |
| Cobalt Dr Mri Surescan | All lots. | DDPB3D4 DDPB3D1 |
| Crome Dr Mri Surescan | All lots. | DDPC3D4 DDPC3D1 |
| Cobalt Xt Hf Crt-D Mri Surescan | All lots. | DTPA2D4 DTPA2D1 |
| Cobalt Vr Mri Surescan | All lots. | DVPB3D1 DVPB3D4 |
| Cobalt Hf Quad Crt-D Mri Surescan | All lots. | DTPB2Q1 DTPB2QQ |
Issue
Medtronic is notifying health care professionals of the potential for reduced shock energy (~79% of programmed energy) during high-voltage (hv) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (crt-ds). Through 03-June-2022, Medtronic has identified 27 devices (0.03% of devices distributed worldwide) that have experienced a reduced-energy shock, which is accompanied by a short circuit protection (scp) alert. Medtronic has not received any reports of permanent harm or death due to this issue.
Medtronic is also requesting hospitals quarantine and return a subset of non-implanted Medtronic Cobalt and Crome icds crt-ds. An identified list (i.e. subset) of specific serial numbers may have a manufacturing non-conformance that can contribute to the potential for reduced shock energy during high-voltage therapy. These devices will undergo additional inspection to ensure conformance to manufacturing specifications, once retrieved from the field.
Recall start date: June 22, 2022
Additional information
Details
Medtronic Inc.
710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
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