FDA recall Z-0522-2024

Medtronic Inc. · Class II · device

Product

Medtronic SynchroMed, Model A10

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.

Distribution

Foreign Distribution

Key facts

Status: Completed
Initiation date: 2020-07-13
Report date: 2023-12-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0522-2024