CLASS II ONGOING Device recall · Reported 20 Jan 2021 · FDA Enforcement Report
CareLink Personal recalled by Medtronic
Medtronic is recalling CareLink Personal, distributed nationwide in the US. The recall was initiated on 12 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0843-2021
- FDA event ID
- 86895
- Recalling firm
- Medtronic, Northridge, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Nov 2020
- FDA classified
- 11 Jan 2021
- Reported
- 20 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 12 Nov 2020 | Recall initiated by company | |
| 11 Jan 2021 | Classified by FDA | +60 days |
| 20 Jan 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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
Questions about this recall
Is CareLink Personal recalled?
Yes. Medtronic recalled CareLink Personal on 12 Nov 2020. The recall is Class II and its status is Ongoing. Recall number Z-0843-2021.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic
All 148| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sphere-9 Catheter recalled by Medtronic | Medtronic | Other | MN |
| Device | CLASS II | Abre Venous Self-Expanding Stent System recalled by Medtronic | Medtronic | Other | Nationwide |
| Device | CLASS II | CareLink SmartSync Device Manager recalled by Medtronic | Medtronic | Device Malfunction | Nationwide |
| Device | CLASS II | CareLink SmartSync Patient Connector recalled by Medtronic | Medtronic | Device Malfunction | Nationwide |
| Device | CLASS II | Medtronic SmartLink software loaded on CareLink SmartSync Device recalled | Medtronic | Device Malfunction | MN |
Other Medical Software recalls
All 903| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT Product Codes recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled | Philips North America | Device Malfunction | MA |
| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |