Medtronic’s HeartWare faces 2 Class I FDA recalls

Medtronic (NYSE:MDT) said today the FDA labeled 2 outstanding global voluntary recalls related to subsidiary HeartWare International‘s HVAD system as Class 1.

A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.

The voluntary recall is related to potential damage to controllers on the device from exposure to moisture, caused by loose power and data connectors, according to a Medtronic press release. The company added that, in the U.S., all clinicians have been notified and acknowledged, while 99% of clinician notifications have been acknowledged globally.

In a warning sent in May and June, HeartWare advised hospital clinicians to inspect HVAD HeartWare controllers for loose connectors during scheduled appointments, and to replace affected controllers with new equipment when necessary. Clinicians were also instructed to communicate safe use instructions for the HVAD system, with a focus on moisture and proper connection to power and data sources.

Damage to the controllers from the stated issue can potentially cause a loss of communication between the controller and the monitor, with reduced ability to detect alarms or interruptions of support due to a pump stop. These issues could result in serious injury or death, Medtronic warned.

The recall affects approximately 8,799 units with model numbers 1400 and 1401, distributed worldwide. A total 308 controller units have been replaced as of Sept. 26, the company said.

A separate global voluntary recall, initiated in August, affected un-implanted, sterile HVAD pump implant kits in hospital inventory. The pumps supplied in the kits could be susceptible to electrical faults and connection failures if fluid enters the driveline-to-controller connector during or after the implant procedure, Medtronic said.

The issue could result in serious injury or death due to electrical faults or connection failures interrupting circulatory support, the company said. Eighty-nine percent of patients globally have acknowledged notifications for the issue, Medtronic added.

The 2nd recall affects model numbers 1103 and 1104 with serial numbers lower than HW25838. As of today, 350 potentially affected kits have been distributed worldwide, with 323 having been returned to HeartWare already.

Medtronic closed its $1.1 billion acquisition of HeartWare in late August.

The $58-per-share deal cleared the field of the 2 major cardiac assist device makers, after Medtronic’s cross-town rival, St. Jude Medical (NYSE:STJ), paid $3 billion for Thoratec in October 2015 (St. Jude is now being acquired by Abbott (NYSE:ABT) for $25 billion). HeartWare’s implantable left ventricular assist devices are designed for end-stage heart failure patients, either as a destination therapy until death or as a bridge to heart transplantation.

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