Summary
The FDA issued a Class II for Medtronic SynchroMed, Model A10 by Medtronic Inc.. Reason: The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of .
Details
Source
Device Recall
External ID
Z-0522-2024
Action Date
2023-12-20
Status
Completed
Category
device
Product Description
Medtronic SynchroMed, Model A10
Lot/Code Info: GTIN 00643169771031, All serial numbers with software version 1.1.300.
Quantity Affected: 2543 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.
Distribution
Foreign Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2020-07-13
Company
Mounds View, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Inc. has 83 FDA actions in our database, including 46 recalls and 37 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Inc. have FDA actions?
Medtronic Inc. has 83 FDA actions in our database, including 46 recalls and 37 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0522-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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