HeartWare Sanguine on FDA Warning Letter Resolution

Last week Ventricular Assist Device maker HeartWare International, Inc. received a warning letter from the U.S. FDA. The company is very keen to ensure that we all know its on top of matters.


HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure.

The FDA’s warning letter, which resulted from an inspection of the company’s operations, development and manufacturing facility in Florida back in January, cites four categories for the company to address. These included procedures for validating device design, including device labeling; procedures for implementing corrective and preventive action (CAPA); maintaining records related to investigations; and validation of computer software used as part of production or quality systems. In other words, procedural issues that the company has keenly pointed out do not require any action by physicians or patients, nor restrict use of HeartWare’s devices.

The company is nonetheless issuing reassurance that it has the matters in hand, promising to respond to the letter within the required 15 days and expecting to implement new and enhanced systems and procedures, and additional actions as may be required to resolve the issues raised in the FDA communication.

Company comments

“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,” said Doug Godshall, President and Chief Executive Officer.

Source: HeartWare International, Inc., PR Newswire



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