On January 2, 2018, the FDA alerted the public that the Agilis Steerable Introducer Sheath’s hemostatic valve, which prevents blood from flowing back through the valve, may fail due to an improper seal of the sheath hub. Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism). An air embolism, a blood vessel blockage caused by one or more bubbles of air or other gas in the circulatory system, can travel to the brain, heart, or lungs causing breathing difficulty, chest pain, and confusion.
The Agilis Steerable Introducer Sheath is used to insert and position various cardiovascular catheters in the heart, including on the left side of the heart through the wall of tissue that separates the right and left chambers of the heart (interatrial septum).
The improper seal occurs when not enough glue is used to reattach the cap to the hub after reprocessing. Too much glue can also block the sheath valve and make the device unusable.
The recalled devices were manufactured and distributed between January 1, 2017, and May 5, 2017. All lot numbers with the model numbers STJ408309, STJ408310, or STJG408324 were recalled.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Alert
Also see the Recall
See also Medical Law Perspectives Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also Medical Law Perspectives Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives Report: Diagnosis and Treatment of Heart Attacks: Liability Issues