Medtronic A820 myPTM Infusion Pump Software Shows Delayed Patient Response
Medtronic is recalling the A820 myPTM Software Application used with SynchroMed infusion pumps because the app is taking longer than expected to respond to patient interactions. Approximately 4365 units are affected worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medical device (infusion pump) inherently capable of causing patient harm if software responsiveness impacts medication management. No illnesses or injuries have been reported, fitting the criterion of a risk-of-harm product without yet-reported injury.
Plain-English summary
Medtronic Neuromodulation is recalling the A820 myPTM Software Application (version v.2x), which is used with the Medtronic SynchroMed Pump and Infusion System. This software allows patients to interact with their implanted pump for medication management.
The recall was initiated following complaints from patients describing delayed responsiveness in the A820 myPTM application. Patients reported that the app is taking longer than expected to respond to their interactions with the implantable pump.
The recall involves approximately 4365 units of the software distributed worldwide. Affected locations include the United States and the following countries and territories: Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, and the United Kingdom.
The recalled product
- Product
- A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- software-delay
- device-responsiveness
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- version v.2x
- UDI/DI 00763000632793
Distribution
Distributed nationwide across the United States.
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