Reported Jan 20, 2021 · Ongoing

CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software…

Medtronic Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219

Is this the product you have?

  • CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool
  • for Diabetes Software Uploader versions3.1.5.000 3.1.2.000
Lot codes and dates
  • 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
Amount recalled
46,461 affected systems

Where it was sold

  • Nationwide

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.