HeartWare ($HTWR) was hit with a Class I recall for its ventricular assist device pumps, adding to its laundry list of woes months after Medtronic ($MDT) acquired the company.
The FDA issued its most serious warning for a recall of some of HeartWare’s ventricular assist devices (HVAD). The company recalled the pumps “due to a design problem with the driveline connector,” or a tube that connects the pump to an external controller and power source, regulators said in a statement.
Problems with the driveline could allow fluid or other material to get into the pump, which could then cause electrical issues or pump stops. The issue “may lead to serious adverse health consequences, including death,” the FDA said.
The recall affects 105 devices distributed across the U.S. Devices included in the recall were manufactured between March 17, 2006, and June 27, 2016.
HeartWare has already addressed the issue with consumers. In July, the company initiated the recall for the HVAD devices in question.
In August, HeartWare sent a letter to customers warning them about the defective devices and asking them to return the pumps. The company is asking doctors to contact the company with questions related to the recall.
HeartWare has traveled a rough road with HVAD, which treats congestive heart failure by pumping blood from the heart to the rest of the body.
In 2013, the FDA slapped a Class I status on the company’s recall of the device. HeartWare recalled the pump because its locking mechanism wasn’t working. The company got three Class I recalls for the device between April 2014 and May 2015.
A brighter moment came in June, when Medtronic said it would buy HeartWare for $1 billion. The deal was meant to boost Medtronic’s Cardiac Rhythm and Heart Failure Management unit and give HeartWare some much-needed stability during product development.
"Combining the unique capabilities of the HeartWare team, which has been entirely focused on mechanical support technologies, with the broad strength of the Medtronic organization provides a unique opportunity to enhance growth in the mechanical circulatory support market," HeartWare CEO Doug Godshall said in a statement at the time of the deal.