St Jude Medical Recalls Pacemakers for Unauthorized Access Risk
St Jude Medical is recalling specific Assurity and Accent pacemaker models 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 addresses a risk of unauthorized access to implanted medical devices, which constitutes a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
St Jude Medical Inc. is recalling specific models of Assurity and Accent pacemakers, including single-chamber, dual-chamber, and CRT-P pulse generators. The recall involves 529,912 units that were distributed worldwide.
The recall was initiated because new pacemaker firmware was developed to further mitigate the risk of unauthorized access to these devices, which utilize radio frequency (RF) communications. The affected devices are indicated for the implantation of pulse generators in patients with conditions such as syncope, presyncope, fatigue, or disorientation, as well as for CRT-P indications in patients with heart failure.
Consumers and healthcare providers should contact St Jude Medical Inc. for further instructions regarding the recall and the installation of the new firmware.
The recalled product
- Product
- Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated…
- Manufacturer
- St Jude Medical Inc.
- Category
- Medical Device — Pacemakers
- Hazard
- Affected units
- 529,912
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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