Recall Alert – Abbott’s (formerly St. Jude Medical’s) implantable cardiac pacemakers

Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott’s (formerly St. Jude Medical’s) Implantable Cardiac Pacemakers: FDA Safety Communication

Date Issued

August 29, 2017

Audience

  • Patients with a radio frequency (RF)-enabled St. Jude Medical implantable pacemaker
  • Caregivers of patients with an RF-enabled St. Jude Medical implantable cardiac pacemaker
  • Cardiologists, electrophysiologists, cardiothoracic surgeons, and primary care physicians treating patients with heart failure or heart rhythm problems using an RF-enabled St. Jude Medical implantable cardiac pacemaker

Medical Specialties

Cardiac Electrophysiology, Cardiology, Cardiothoracic Surgery, Heart Failure

Devices

Abbott’s (formerly St. Jude Medical’s) implantable cardiac pacemakers, including cardiac resynchronization therapy pacemaker (CRT-P) devices, provide pacing for slow or irregular heart rhythms. These devices are implanted under the skin in the upper chest area and have connecting insulated wires called “leads” that go into the heart. A patient may need an implantable cardiac pacemaker if their heartbeat is too slow (bradycardia) or needs resynchronization to treat heart failure.

The devices addressed in this communication are the following St. Jude Medical pacemaker and CRT-P devices:

  • Accent
  • Anthem
  • Accent MRI
  • Accent ST
  • Assurity
  • Allure

This communication does NOT apply to any implantable cardiac defibrillators (ICDs) or to cardiac resynchronization ICDs (CRT-Ds).

Visit the FDA Website for more details about this recall and firmware update https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm573669.htm

By |2018-02-13T23:04:29+00:00September 1st, 2017|Medical Recalls|Comments Off on Recall Alert – Abbott’s (formerly St. Jude Medical’s) implantable cardiac pacemakers