Model note · Pacemaker
Abbott Assurity MRI pacemakers PM1272
Assurity MRI is Abbott's MR Conditional bradycardia pacemaker family, built on the Assurity platform with extra hardware to tolerate MRI scanning. It is programmed with the Merlin PCS programmer, followed remotely through Merlin.net, and paired with the Tendril MRI lead as part of an MR Conditional system. For hospital teams the main touch points are programmer software, MRI scan preparation and recall driven follow up rather than bench repair.
The model
Maker, model and type.
- Maker
- Abbott (St. Jude Medical)
- Model
- Assurity MRI pacemakers PM1272 (single chamber) and PM2272 (dual chamber)
- Device type
- Pacemaker
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Models | Assurity MRI PM1272 and PM2272; sister Endurity MRI PM1172 and PM2172 | Source |
| MRI conditions (original approval) | 1.5 T, 64 MHz, cylindrical bore, spatial gradient 30 T/m, whole body SAR 2 W/kg, head SAR 3.2 W/kg, slew rate 200 T/m/s, full body | Source |
| MRI hardware changes | Lower feedthrough capacitance, band stop MR filter assembly, reshaped can, unique radiopaque MRI x ray marker | Source |
| MRI Settings modes | Asynchronous pacing or pacing off, with sensing disabled during the scan | Source |
| Pulse amplitude tolerance (test requirement) | 5 V peak plus or minus 20%, from beginning of life to ERI | Source |
| Shelf life | 18 months, limited by the battery | Source |
| Companion lead | Tendril MRI LPA1200M: 7.9 F, steroid eluting, bipolar, active fixation, IS-1 | Source |
| Support tools | Merlin PCS programmer software 3330, MRI Activator EX4000 handheld | Source |
| FDA approval | PMA P140033, MR Conditional pacing system | Source |
Recalls
Known FDA recalls.
- Z-1530-20212021-03-15
Class 1: moisture ingress through header and feedthrough from incomplete epoxy mixing (2015 to 2018 builds).
FDA record - Z-0031-20182017-08-28
Firmware update to reduce risk of unauthorised RF access (Assurity MRI PM1272, PM2272).
FDA record
Safety
Safety warnings from the record.
- Sensing is disabled in MRI Settings, so the patient is paced asynchronously or not at all during the scan. Source
- Rate adaptive pacing may be unsuitable for patients with angina or other symptoms worsened by faster heart rates. Source
- Moisture affected devices may reach ERI or EOS without warning; pacemaker dependent patients who cannot be remotely followed need extra risk review. Source
Sources
Where this note comes from.
- FDA PMA P140033 Summary of Safety and Effectiveness Data, Assurity MRI and Endurity MRI
- FDA recall Z-1530-2021, Assurity pacemakers
- FDA recall Z-0031-2018, Assurity MRI cybersecurity firmware
- openFDA MAUDE problem counts, brand ASSURITY MRI
Not covered: Battery capacity, projected longevity, size and weight are in Abbott's reference manual, which was not read. MRI conditions listed are from the 2014 approval; later supplements may have widened them (for example to 3 T), so the current MRI-Ready Systems Manual must be checked. Implanted devices have no user error codes. MAUDE counts include many lead and clinical reports and are not generator failure rates. The manufacturerUrl points to the FDA summary.
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