FDA Class I Recall: Its Most Serious
The FDA said the recall of Agilis Steerable Introducer Sheath devices – made by Sterilmed Inc. – is a Class I recall. That’s the agency’s most serious type of recall. This sheath device is used to insert and position cardiovascular catheters. It is sometimes used on the heart’s left side through the wall of tissue separating the heart’s right and left chambers.
The FDA said the sheath’s hemostatic valve is at risk of failing because of an improper seal on the sheath’s hub. The valve is designed to keep blood from flowing back through the valve.
The FDA said, “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).”
The improper seal happens when there isn’t enough glue used to reattach the sheath’s cap after use. But too much glue can also block the valve and make the device unusable, according to the FDA.
FDA said, “The use of affected products may cause serious health consequences for patients, including death.”
Some 112 affected devices are included in the recall, which covers sheaths made between Jan. 1, 2017, and May 5, 2017, according to the FDA.
In addition, patients with a lower body mass index may be more at risk if there is blood loss, said the FDA. Smaller patients and those with a pre-existing lower lung capacity may also be more susceptible to air embolisms.
The FDA advised health care facilities and providers to search their inventories for the sheath and return any unused sheaths to Sterilmed. The agency said providers should also continue to monitor patients treated with the sheath, just as they would normally do.
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A Sterilmed representative said that the company initiated the recall in June and that it has not received any reports of adverse events related to the devices.