St Jude Medical Recalls Assurity MRI Pacemakers for Firmware Update
St Jude Medical is recalling 164,366 Assurity MRI pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
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: The recall involves a high-risk medical device (pacemaker) with a security vulnerability (unauthorized access) that poses a risk of harm, but the source text does not report any actual injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
St Jude Medical Inc. is recalling 164,366 units of the Assurity MRI pacemaker, specifically models PM1272 and PM2272. These devices are indicated for the implantation of single-chamber, dual-chamber, or CRT-P pulse generators in patients with conditions such as syncope, presyncope, fatigue, or disorientation. The affected units were distributed worldwide.
The recall is being conducted to install new pacemaker firmware designed to further mitigate the risk of unauthorized access to the devices. The risk is associated with the pacemakers' utilization of radio frequency (RF) communications. The source text does not report any specific injuries, illnesses, or deaths associated with this vulnerability.
Patients with these implanted devices should contact their healthcare provider or St Jude Medical to determine if their specific device is affected and to discuss the installation of the updated firmware. The recall includes a specific list of serial numbers to identify the affected units.
The recalled product
- Product
- Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those…
- Manufacturer
- St Jude Medical Inc.
- Category
- Medical Device — Pacemaker
- Affected units
- 164,366
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 recalled by St Jude Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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