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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 4,365
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.
Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighFemoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
Similar recalls
- HighMedtronic Implantable Drug Pumps Recalled for Software Defects
FDA (Devices) · 2025-01-08
- HighMedtronic SynchroMed II and III Implantable Pumps Recalled for Software Defects
FDA (Devices) · 2025-01-08
- SevereMedtronic SynchroMed II Software Card Recall for Priming Bolus Function
FDA (Devices) · 2017-03-08
- HighSynchroMed II and III implantable pumps recalled for software issues
FDA (Devices) · 2025-01-08
- SevereMedtronic SynchroMed II Implantable Pumps Recalled for Overinfusion Risk
FDA (Devices) · 2014-05-14
- HighMedtronic Recalls SynchroMed II Implantable Pumps Due to Alarm Failure
FDA (Devices) · 2015-06-03