Class I recall issued for 21 Medtronic CRT-Ds, ICDs

Daniel Allar | | Cardiovascular Business | Heart Rhythm

The FDA announced on Feb. 26 a Class I recall for nine of Medtronic’s cardiac resynchronization therapy with defibrillation (CRT-D) devices and 12 of its implantable cardioverter-defibrillators (ICDs).

Due to a manufacturing defect, a gas mixture can enter the devices and hamper their ability to provide shock therapy. A delay or inability of the devices to deliver a shock to the patient could result in serious injury or death, the FDA warned.

Medtronic first informed its customers of the flaw on Jan. 22 and suggested they consider prophylactic device replacement, which will be covered under a supplemental warranty.

The affected units were manufactured from July 13, 2013, to August 8, 2017. Devices in the recall include the Evera and Visia lines of ICDs, as well as the Amplia, Claria, Compia and Viva CRT-Ds.

""
Daniel Allar

Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.

Related Content

LAAC with Watchman FLX reduces bleeding risks after AFib ablation
Eko Health’s AI platform for digital stethoscopes granted new CPT code
Predicting sudden cardiac death after a heart attack may be impossible—for now
Concomitant ablation surgery during heart operations boosts long-term survival
Johnson & Johnson MedTech gains FDA approval for Varipulse PFA system
Boston Scientific agrees to acquire AFib ablation company

Around the web

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Radiology Business
What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."