St Jude Medical Recalls Pacemakers for Unauthorized Access Risk
St Jude Medical is recalling specific Anthem and Allure/Relieve pacemakers to mitigate 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 risk-of-harm product (unauthorized access to a medical device) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
St Jude Medical Inc. is recalling approximately 102,684 units of Anthem and Allure/Relieve pacemakers. The affected model numbers include PM3210, PM3212, PM3222, PM3242, PM3262, PM3542, PM3224, and PM3244. These devices are indicated for the implantation of single-chamber or dual-chamber pulse generators, or CRT-P, in patients with conditions such as syncope, presyncope, fatigue, or heart failure.
The recall is being conducted because new pacemaker firmware was developed to further mitigate the risk of unauthorized access to pacemakers that utilize radio frequency (RF) communications. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The affected units were distributed worldwide. Patients with these specific pacemaker models should contact their healthcare provider or St Jude Medical to determine if their device is affected and to discuss the availability of the updated firmware.
The recalled product
- Product
- Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 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…
- Manufacturer
- St Jude Medical Inc.
- Category
- Medical Device — Pacemaker
- Hazard
- Affected units
- 102,684
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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