Medtronic Inc. Recall 86895
Description: CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
Medtronic Inc. Recall 86895 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0843-2021 |
| Event ID | 86895 |
| Event Description | CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000 |
| Product Type | Devices |
| Distribution | U.S. Nationwide O.U.S. Worldwide Refer to Associated Documents and uploaded Consignee Lists/Spreadsheets. -Australia New Zealand -Canada -EMEA -Greater China -India -Japan -Latin America -South Korea -Southeast Asia -US |
| Quantity | 46,461 affected systems |
| Recall Reason | Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software. |
| Device Classification | 20210120 |
| Device Code Info | CareLinkTM Personal (MMT-7333) using CareLink Uploader (ACC-7350) UDI (GTIN/UPN): 00763000424121 CareLinkTM system (MMT-7350) using CareLink Uploader (ACC-7350) UDI (GTIN/UPN): 00763000424138 |
| Center Classification Date | 20210111 |
| Recall Initiation Date | 20201112 |
| Recalling Firm | Medtronic Inc. |
| Initial Notification | Letter |
| Similar To |