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Completed

Medtronic SynchroMed, Model A10

FDA Recall Z-0522-2024 · Posted 2023-12-09

Recalling FirmMedtronic Inc.
Recall StatusCompleted
Product CodeLKK
Date Initiated2020-07-13
Product Quantity2543 units

Reason for Recall

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.

Firm Action

Medtronic issued a SAFETY NOTIFICATION to its consignees on 07/13/2020 by letter. The notice explained the problem with the device and requested the software be upgraded to version 1.1.342.

Root Cause

Software Design Change

Distribution Pattern

Foreign Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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