Medtronic Pulls Plug On Heart Implant Device Amid Growing Concerns Over Patient Safety

Medtronic PLC MDT announced Thursday that it is stopping the distribution and sale of the Medtronic HVAD System, an implantable heart pump, after numerous data indicated higher occurrences of adverse events, including stroke and mortality, as compared to other circulatory-support devices.

What Happened: On Thursday morning, the company notified physicians to halt new implants of the HVAD System and shift to an alternative form of mechanical circulatory support. Medtronic announced that it is curating an ongoing support program for patients who have had an HVAD implanted, and caregivers and health care professionals who participate in their care.

“We recognize this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them in coordination with their physicians,” Medtronic President of the Mechanical Circulatory Support business Nnamdi Njoku said in a statement.

Medtronic said it is working closely with the FDA and other regulatory agencies in order to effectively communicate information regarding the HVAD device recall, including the support for patients implanted with the HVAD device.

What’s Next: Medtronic estimates the financial impact of the HVAD recall to be “neutral to slightly accretive to fiscal year 2022 non-GAAP diluted EPS. The HVAD System and associated accessory revenue was $141 million in the fiscal year 2021. In addition, the potential loss of revenue was contemplated in the guidance issued by the company on May 27, 2021.”

MDT Price Action: MDT shares were down 0.59% at $123.07 on Thursday's close.

Photo by Tony Webster on Flickr