The FDA yesterday issued a recall for Johnson & Johnson (NYSE:JNJ) subsidiary Sterilmed’s reprocessed Agilis steerable introducer sheaths over issues with possible air embolisms, labeling the recall as a Class I.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
Sterilmed’s Agilis steerable introducer sheath is designed for the insertion and positioning of cardiovascular catheters in the heart, including the left side of the heart through the interarterial septum.
The devices are being recalled over issues with the incorporated hemostatic valve, designed to prevent blood flow back through the valve. The FDA noted that these valves may fail due to an improper seal of the sheath hub which could allow blood to leak back to the hub, resulting in the device’s cap falling off or a possible difference in pressure that could allow air into the circulatory system causing an air embolism.
The improper sealing occurs due to a lack of glue used to reattach the cap to the hub after reprocessing, while too much glue could block the sheath valve and make the device unusable. Results from the issues include serious health consequences for patients, including death, according to the FDA.
The federal watchdog said that patients with lower body mass index may be more at risk if blood loss occurs, and smaller patients and patients with pre-existing decreased pulmonary reserves may be extra susceptible to air embolisms.
The federal watchdog said that the recall affects 112 devices manufactured and distributed between January 1, 2017 and May 5, 2017, with product code PNE and model numbers STJ408309, STJ408310, STJG408324. All product lots are indicated in the recall, according to the FDA release.
Sterlimed instructed users of the device to examine inventory for affected devices and return unused products to the company.