| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00812-1 |
| Product Name/Description |
Medtronic Cobalt and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
Multiple model and serial numbers
Multiple ARTGs |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/06/2022 |
| Responsible Entity |
|
| Reason/Issue |
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. The devices will undergo additional inspection to ensure conformance to manufacturing specifications. Medtronic issued a communication in June 2022 to implanting physicians regarding the potential for reduced shock energy to occur in Cobalt/Crome devices (RC-2022-RN-00811-1). |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic are advising customers to Identify and quarantine any non-implanted serial numbers (purchased or consigned). All unused product should be returned to Medtronic.
Users should refer to RC-2022-RN-00811-1 for implanted products |
| Contact Information |
0404 090 297 - Zuben Florence |