CareLink Personal Software Therapy Management Software Tool for… — Class II medical device recall Z-0843-2021
Ongoing recall by Medtronic Inc., reported 2021-01-20, distributed nationwide. Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therap
| Recall number | Z-0843-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Northridge, CA, United States |
| Recall initiated | 2020-11-12 |
| Classified | 2021-01-11 |
| Reported by FDA | 2021-01-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, IN, JP, KR, NZ |
| Quantity | 46,461 affected |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000424121, 00763000424138 |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0843-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.