Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medtronic SynchroMed Recalled by Medtronic Inc. Due to The previous software application version (1.1.300) is missing...

Date: July 13, 2020
Company: Medtronic Inc.
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc. directly.

Affected Products

Medtronic SynchroMed, Model A10

Quantity: 2543 units

Why Was This Recalled?

The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.

Where Was This Sold?

Foreign Distribution

About Medtronic Inc.

Medtronic Inc. has 85 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report