A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Summary
The FDA issued a Class II for A820 myPTM Software Application associated with Medtronic SynchroMed Pump and In by Medtronic Neuromodulation. Reason: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump..
Details
Source
Device Recall
External ID
Z-1506-2025
Action Date
2025-04-09
Status
Ongoing
Category
device
Product Description
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Lot/Code Info: version v.2x, UDI/DI 00763000632793
Quantity Affected: 4365 units
Reason for Recall
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-09
Company
Minneapolis, 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 182 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 clearance.
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 Neuromodulation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neuromodulation have FDA actions?
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1506-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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