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Class I Recall Announced for Johnson & Johnson Heart Device Over Potentially Faulty Valve

Personal Injury Lawyer | Medical Device Lawyer | Defective Product Lawyer

The U.S. Food & Drug Administration (FDA) has announced a Class I medical device recall for certain Agilis Steerable Introducer Sheaths, a heart device manufactured by Johnson & Johnson’s Sterilmed, Inc. subsidiary.

A Class I recall is the FDA’s highest-level recall, and indicates  that use of a device may cause serious health problems, including death.

Valve Failure Could Result in Blood Loss, Formation of Air Embolism

The Agilis Steerable Introducer Sheath is used to insert and position various cardiovascular catheters in the heart. A hemostatic valve on the device prevents blood from flowing back through the valve.

In an alert published by the FDA on January 2nd, the agency warned that the valve may fail due to an improper seal of the sheath hub. Such an occurrence could allow blood to leak through the hub, cause the cap to fall off during the procedure, or create a difference in pressure that allows for the formation of an air embolism.

According to the agency, smaller patients face a higher risk of blood loss from an improper seal. Those with pre-existing decreased pulmonary reserves may be more vulnerable to air embolisms.

An improper seal will occur if an insufficient amount of glue is used to reattach the cap to the hub after reprocessing. However, an excess amount of glue may block the sheath valve and make the device unusable.

Sterilmed Recall Includes 112 Devices Distributed From January 1 to May 5, 2017

The recall includes all product lots of Agilis Steerable Introducer Sheaths bearing the following lot and model numbers:

  • STJ408309
  • STJ408310
  • STJG408324

112 devices distributed and manufactured from January 1, 2017 to May 5, 2017 are included.

Healthcare providers and facilities have been advised not to use the Agilis Steerable Introducer Sheaths included in this action. Unused product should be returned to Sterilmed.

Patients who have already been treated with a recalled Agilis Steerable Introducer Sheath should be monitored as normal.

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Our Undefeated Personal Injury Lawyers are investigating the Agilis Steerable Introducer Sheath recall and will publish an update should more information become available.

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