St Jude Medical recalls Merlin PCS programmer software versions 24.1.1 rev1 (US) and others for security updates to protect implantable cardiac devices from unauthorized access.
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
St Jude Medical is recalling specific software versions of their Merlin PCS programmer to strengthen security for high-voltage cardiac devices. This update helps prevent unauthorized device access, which could compromise patient safety.
Older software versions could be vulnerable to unauthorized access, potentially allowing hackers to interfere with device function. This might lead to unintended device behavior, but the risk is mitigated by the security update.
Patients with high-voltage implantable cardiac devices (ICDs) or cardiac resynchronization therapy defibrillators (CRT-D) who use the Merlin PCS programmer software versions 24.1.1 rev1 (US) and others are affected. Medical professionals who manage these devices are most at risk.
Check if you have the Merlin PCS programmer (Model # 3650) with software versions 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), or 23.1.4 rev 1 (Canada).
Install the latest firmware version from St Jude Medical to strengthen security against unauthorized device access.
No, the recall does not require immediate discontinuation. The update can be applied to strengthen security.
For older devices not capable of accepting the firmware, St Jude Medical advises permanently disabling the RF communication capability.
Software versions 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), and 23.1.4 rev 1 (Canada) are affected.
We’ve drafted a message you can send St Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2329-2018 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-2329-2018 from St Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
