Class II — Medtronic Inc.
| Recalling firm | Medtronic |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | 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 |
| Quantity | 46,461 affected systems |
| 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 |
| Initiated | 2020-11-12 |
| Classified | 2021-01-11 |
| Recall number | Z-0843-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic Inc. (Z-0843-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86895/
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