HeartWare Hit With Another LVAD Recall

The company had complaints of contamination at the site where the driveline enters the controller.

Nancy Crotti

HeartWare International is voluntarily recalling an unspecified number of LVADs due to the possibility of electrical faults that could stop the pump should the driveline become contaminated.

The driveline connects the LVAD pump, which is implanted through the heart wall, to the controller, which is worn outside the body. HeartWare said it had received complaints of contamination at the site where the driveline enters the controller. Such contamination could occur during implant or post-operatively, due to fluid ingress into the driveline. It has been seen most often within 30 days of LVAD implantation, the company said in a recall notice. Patients could suffer injury or death should the pump stop, the company said.

HeartWare sent the notice to hospitals globally, asking them to return sterile, wrapped units with serial numbers lower than HW25838. The company did not say when the units were manufactured, but did say it had "implemented manufacturing process improvements designed to prevent driveline connector contamination in new implant kits."

FDA has not yet given the recall a classification. Its records indicated at least one patient injury due to foreign material in the driveline, in a patient who had had previous driveline infections. Another patient was listed as having an infection around the driveline and received antibiotics, according to FDA records.

This is the second recall related to ventricular-assist devices for HeartWare since June, when the company recalled more than 18,000 batteries for devices it sold between 2013 and 2015. In the battery recall, which FDA designated Class I, the agency warned that the batteries may lose power prematurely due to faulty cells.

Framingham, MA-based HeartWare is also in the process of being acquired by Medtronic for $1.1 billion. A Medtronic spokesperson said at the time of the first recall that the medical device giant was aware of the recall when it offered to buy HeartWare.

The deal, already approved by both companies' boards of directors, will expand Medtronic's reach to more heart-failure patients. It also puts Medtronic on more even footing in the minimally invasive ventricular assist device market with St. Jude Medical, which acquired LVAD-maker Thoratec and its HeartMate III technology for $3.3 billion in 2015. HeartMate III won the CE Mark in October, and won FDA approval earlier last year to enlarge the pivotal trial for the next-generation device.

In January, HeartWare shares plunged by 35% on news of lower earnings and uncertainty about the future of its new MVAD system.

Nancy Crotti is a contributor to Qmed.

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