St. Jude Medical Recalls Merlin PCS 3650 Programmer for Firmware Update
St. Jude Medical is recalling 10,453 Merlin PCS 3650 programmers worldwide to install new firmware that mitigates the risk of unauthorized access to pacemakers.
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 security vulnerability (unauthorized access) in a medical device, which poses a risk of harm, but the source text does not report any actual injuries, illnesses, or deaths, fitting the criteria for a High severity score.
Plain-English summary
St. Jude Medical Inc. is recalling 10,453 units of the Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1. These devices are portable, dedicated programming systems designed to interrogate, program, display data, and test St. Jude Medical implantable devices. The recall covers units distributed worldwide.
The recall is being conducted to install new pacemaker firmware. This update is intended to further mitigate the risk of unauthorized access to pacemakers that utilize radio frequency (RF) communications. The source text does not report any specific injuries, illnesses, or deaths associated with this recall.
Healthcare providers and consumers should contact St. Jude Medical Inc. for instructions on how to obtain the firmware update. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- Product
- Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
- Manufacturer
- St Jude Medical Inc.
- Hazard
- Affected units
- 10,453
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version 23.1.1
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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