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News From the Food and Drug Administration
December 1, 1999

Complications Related to Vascular Hemostasis Devices

Author Affiliations

Copyright 1999 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.1999American Medical Association

JAMA. 1999;282(21):1995. doi:10.1001/jama.282.21.1995

The FDA is informing practitioners about adverse events involving the use of vascular hemostasis devices following percutaneous femoral arterial punctures in patients undergoing diagnosis and treatment for cardiovascular disease. Complications include hematoma, retroperitoneal bleed, pseudoaneurysm, late bleeding, and, infrequently, death. Similar complications occur with manual compression.

After analyzing the specific circumstances that led to adverse events reported since 1996, the FDA believes the following recommendations may be helpful in minimizing injuries involving closure devices: