Faulty seal prompts Class I recall of Sterilmed Agilis device

January 05, 2018

Sterilmed Inc. (Plymouth, MN) has earned the dubious distinction of being the first medical device company to be hit with an FDA recall in 2018.

Image courtesy FDA.

The Class I recall—the agency’s most serious classification— targets the Reprocessed Agilis Steerable Introducer Sheath, which is used to insert and position cardiovascular catheters in the heart, explains FDA on its website.

The reason for the recall is as follows.

“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,” writes FDA. “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 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,” notes FDA.

Devices undergoing a Class I recall may cause serious injuries or death, so it is imperative that healthcare facilities and clinicians examine their inventory and not use any of the affected products. For specific information on the product codes and model and lot numbers of the affected devices, of which there are 12, go to the FDA website.

A major player in the medical device reprocessing and remanufacturing space, Sterilmed was acquired by Ethicon Endo-Surgery Inc., a Johnson & Johnson Co., in 2011.

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