FDA unveils HeartWare warning letter for company's ventricular assist device

HeartWare's Ventricular Assist System

The FDA slapped HeartWare International ($HTWR) with a formal warning letter one month after citing the company for safety issues related to its HeartWare Ventricular Assist Device (HVAD) system.

The Framingham, MA-based devicemaker drew the agency's ire last month, as the FDA said it would issue a warning letter against the company for violations resulting from a January inspection of its Miami Lakes, FL, facility. The published letter spells out HeartWare's latest offenses, including design and software malfunctions for its HVAD system that led to customer complaints and in some cases, death, MassDevice reports.

As the note states, the company received at least 27 complaints between February 2010 and November 2013 related to HVAD controller failure, including two deaths and four serious injuries. The letter acknowledges that the company initiated corrective actions, but failed to carry out the appropriate procedures to address the complaints or design defects. The agency also cited three additional violations, including HeartWare's failure to maintain a record of product investigation, failure to establish and maintain procedures for validating device design, and failure to validate computer software for its intended use.

Regulators gave HeartWare 15 business days to correct the noted violations and to lay out a game plan for how to prevent similar incidents in the future, according to the FDA letter. For its part, the company seems willing to comply with agency's requests.

"HeartWare is committed to providing the highest quality products in compliance with FDA regulations to ensure the safety and welfare of patients who rely on our devices, and we are dedicating the resources necessary to address the items discussed in the letter," CEO Doug Godshall said in a statement at the time the letter was announced.

The warning letter comes on the heels of more regulatory woes for HeartWare, as the company continues to deal with safety issues related to its HVAD system. In May, the devicemaker issued a voluntary correction notice about a premature battery depletion and routine battery handling in response to customer complaints. The company described four deaths related to its HVAD device, but said that they were not directly related to a faulty battery.

In April, the FDA hit the company with a Class I recall--its most serious designation--for problems connected to its HVAD system. HeartWare had initiated corrective action for the device in December 2013 in response to eight consumer complaints that the system's driveline connector failed to engage. Four of the cases resulted in a temporary pump stop, but none resulted in injury, the company said in an earlier statement.

- read the MassDevice story
- here's the warning letter
- here's HeartWare's statement

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