Medtronic Inc.: Medical Device Recall in 2023 - (Recall #: Z-0522-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Medtronic SynchroMed, Model A10

Product Classification:

Class II

Date Initiated: July 13, 2020

Date Posted: December 20, 2023

Recall Number: Z-0522-2024

Event ID: 93401

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.

Status: Completed

Product Quantity: 2543 units

Code Information:

GTIN 00643169771031, All serial numbers with software version 1.1.300.

Distribution Pattern:

Foreign Distribution

Voluntary or Mandated:

Voluntary: Firm initiated