Medtronic CareLink Diabetes Software Recalled for Data Transfer Errors
Medtronic is recalling CareLink Personal and System software due to potential RF interference during data uploads, which may cause incomplete basal rate information and inappropriate therapy changes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software defect could lead to inappropriate therapy changes, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Medtronic Inc. is recalling CareLink Personal and CareLink System Therapy Management Software Tools for Diabetes, specifically Software Uploader versions 3.1.5.000 and 3.1.2.000. The recall affects 46,461 systems distributed in the United States and worldwide, including regions such as Australia, New Zealand, Canada, EMEA, Greater China, India, Japan, Latin America, South Korea, and Southeast Asia.
The recall is issued because radio frequency (RF) interference from surrounding devices or equipment can occur at any point during data upload. This interference may affect the data transfer between the insulin pump and the CareLink software, potentially leading to incomplete basal rate information being transmitted. This error creates a potential for inappropriate changes in therapy.
Consumers using the affected software versions should refer to the associated documents and uploaded consignee lists to verify if their systems are affected. Users should follow instructions provided by Medtronic regarding software updates or replacements to ensure accurate data transfer and therapy management.
The recalled product
- 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
- Manufacturer
- Medtronic Inc.
- Affected units
- 46,461
Distribution
Distributed nationwide across the United States.
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