Model note · Pacemaker
Medtronic Azure XT and Azure S MRI SureScan pacemakers
Azure is Medtronic's family of single and dual chamber MRI conditional pacemakers for bradycardia, implanted by cardiologists and followed up in device clinics. Its distinctive feature is BlueSync Bluetooth telemetry, which lets the implant talk to the tablet-based CareLink SmartSync programmer and to patient phone apps for remote monitoring, alongside AF detection, Reactive ATP and the MVP mode that limits unneeded right ventricular pacing.
The model
Maker, model and type.
- Maker
- Medtronic, Inc.
- Model
- Azure XT and Azure S MRI SureScan pacemakers (DR and SR)
- Device type
- Pacemaker
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Models | Azure XT DR W1DR01, Azure XT SR W1SR01, Azure S DR W3DR01, Azure S SR W3SR01 | Source |
| Connector | IS-1 BI/UNI | Source |
| Mass | 22.5 g | Source |
| Volume | 12.75 mL (DR) and 12.25 mL (SR) | Source |
| Size (H x W x D) | 46.6 x 50.8 x 7.4 mm (DR); 42.6 x 50.8 x 7.4 mm (SR) | Source |
| Telemetry | BlueSync Bluetooth, used with CareLink SmartSync device manager, MyCareLink Heart app or MyCareLink Relay | Source |
| AF detection accuracy (manufacturer claim) | 95 to 96% episode positive predictive value | Source |
| PMA | Approved under PMA P980035 supplements (for example S539, 2018) | Source |
Recalls
Known FDA recalls.
- Z-2507-20202020-06-04
Rare SmartSync first-interrogation sequence could temporarily suspend battery measurement, Capture Management and other features (Azure XT DR); sister entries cover XT SR, S DR and S SR.
FDA record - Z-1525-20212021-04-06
Longevity estimation error early in device life with a unipolar RA or RV pacing vector; fixed by software update.
FDA record - Z-1924-20252025-04-29
Azure S DR (W3DR01): possible sudden battery failure without alarm, power-on resets and interruption of therapy.
FDA record - Z-2127-20252025-06-17
SmartSync software update to remove a possibly erroneous electrical reset pop-up on interrogation.
FDA record
Safety
Safety warnings from the record.
- Some Azure S DR devices may lose battery power suddenly without an alarm, interrupting pacing; pacemaker-dependent patients are at risk of syncope or cardiac arrest. Source
- MRI conditions are model and lead specific; check them with the Medtronic MR conditional tool rather than assuming any Azure system is safe to scan. Source
- Electromagnetic interference is a recurring MAUDE problem term (about 410 reports) for Azure, so ask about EMI exposure when investigating unexpected behaviour. Source
Sources
Where this note comes from.
- Medtronic Azure MRI SureScan pacemaker product page (US HCP)
- openFDA PMA records, trade name Azure
- openFDA MAUDE problem counts, Medtronic Azure
- openFDA recalls, Azure by Medtronic
Not covered: The Azure device manual (M964338A001B) and the Medtronic product performance report could not be opened, so programmable ranges, longevity tables, RRT and EOS indicators and MRI scan conditions are not included; implants have no user error codes, and programmer messages are not listed.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Pacemaker