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

An additional recall has been issued on August 5th 2019:

Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Certain Ellipse Implantable Cardioverter Defibrillators
  • Lot Numbers: All lots manufactured between April 5, 2019 – May 29, 2019
  • Model Numbers: CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, CD2411-36Q
  • Manufacturing Dates: April 5, 2019 to May 29, 2019
  • Distribution Dates:  May 6, 2019 to June 14, 2019
  • Devices Recalled in the U.S.: 108
  • Date Initiated by Firm: June 20, 2019

Device Use

Abbott implantable cardioverter defibrillators provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. These cardiac devices are implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. A patient may need an implantable cardiac device if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.

VISIT THE FDA WEBSITE FOR THIS MOST RECENT RECALL – 

FDA WEBSITE FOR RECALLS

Date Issued

August 29, 2017

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

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 |2019-08-05T16:34:27+00:00August 5th, 2019|Medical Recalls|Comments Off on Recall Alert – Abbott’s (formerly St. Jude Medical’s) implantable cardiac pacemakers