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The Food and Drug Administration (FDA) has notified health professionals, and advised patients, about rare but serious complications—including deaths—from the use of negative pressure wound therapy (NPWT).

Negative pressure wound therapy devices can help in the healing and closure of wounds. They create negative pressure (a vacuum) at well-sealed wound sites that can help remove fluids and infectious materials and draws wound edges together.

FDA issued a notification to health professionals and advice for patients regarding the complications with NPWT on Nov. 13, 2009.

In the notifications, the agency alerted the public and health professionals that serious complications, especially bleeding and infection, have been reported in some patients using NPWT devices. These complications can occur wherever NPWT is used, including hospitals, long-term care facilities, and at home.

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