Class 2 Device Recall CareLink Personal/CareLink System

• Date Initiated by Firm: November 12, 2020
• Create Date: January 11, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0843-2021
• Recall Event ID: 86895
• 510(K)Number: K151236
• Product Classification: Sensor, glucose, invasive - Product Code MDS
• 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
• Code Information: 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
• FEI Number: 3003166194
• Recalling Firm/ Manufacturer: Medtronic Inc.; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Pamela Reese; 818-576-3398
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: On 11/19/2020, the firm sent an "URGENT FIELD SAFETY NOTIFICATION" Letter via email, fax, mail and/or phone to its U.S. Customer, and on 12/07/2020, the firm initiated O.U.S Notification using approved regional methods. The Notification Letter informs customers that after the release of an updated uploader software version the following issues/scenarios may result: 1. Some reports may be missing all programmed basal rates in the device. This may result in a blank value on the Device Settings report of the 24-hour basal total. 2. Some reports may only display certain programmed basal rates and some basal rates in the device may be missing from the reports. This may result in a miscalculation on the Device Settings report of the 24-hour basal total. The following reports may be affected by these issues include: Device Settings, Daily Review/Daily Details, Weekly Review, and Sensor & Meter Overview. These reports have been utilized to adjust therapy settings or to transfer settings from an old pump to a new pump. If all of the following are true, it could lead to either over- or under-delivery of insulin which may result in low blood glucose (hypoglycemia, loss of consciousness), and/or high blood glucose (hyperglycemia): a) adjustments were made to therapy settings or if therapy settings were transferred from one device to another, and b) these actions were taken based on a report generated using CareLink" uploader version 3.1.5.000 that has missing or incomplete basal rates, and c) you are using Manual Mode The Recalling Firm is instructing customers to: 1. Install the new CareLink" uploader version 3.1.6.000 available within the CareLink" software to each computer where you upload devices. To confirm your current uploader version or to learn how to install the latest uploader, see the FAQ section at the end of this letter. 2. If you have had insulin settings adjusted that may have been made based on an impacted CareLink" report, review your settings
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MDS