HeartWare International ($HTWR) reports that at least 11 of 2,900 implants involving its celebrated HVAD heart pump developed a troubling mechanical problem--a part that could become partially separated from the main unit after extended use.
No patient has had any health problems based on the malfunction, the company disclosed in a recent regulatory filing. But HeartWare launched a "voluntary field correction" to make sure the breakdown isn't more widespread.
The malfunction stems from the rear portion of the HVAD pump's driveline connector housing, which HeartWare disclosed became either partially or entirely separated from the front part of the driveline connector after extended use. Surgeons are warned that a repair might be necessary when this happens, and that they should inspect the incriminating part during routine clinic visits. They can tighten the connector housing by hand, but the company recommends contacting HeartWare to arrange a company inspection and permanent repair.
If there's any good news it might be this: HeartWare said the repair process shouldn't majorly impact its financials.
The company's ventricular assist system won FDA approval last November, a mini-pump designed to help save heart failure patients who are waiting for a transplant. It's had a CE mark since 2009.
- read the SEC filing
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