J & J heart device recalled by FDA

The US Food and Drug Administration (FDA) issued a class 1 recall of a heart device manufactured by Johnson & Johnson. The Agilis Steerable Introducer Sheath devices were distributed for four months from January 1 to May 5. The FDA believes that there is a faulty valve in the device, known as the hemostatic valve. This valve is designed to prevent blood from flowing back through it. Studies indicate that it may fail as a result of an improper seal.[1]

The Agilis Steerable Introducer Sheath is used during cardiovascular catheter insertion and positioning. The device is designed to assist with catheter navigation including procedures that separate the right and left chambers. The FDA believes that 112 devices are affected in the recall including Model Numbers STJ408309, STJ408310, and STJG408324 manufactured and distributed between January 1, 2017 and May 5, 2017.[2]

The FDA classified this recall as a Class 1 meaning that it is a dangerous or defective product that predictably could cause serious health problems or death.[3] This is the most serious recall class issued by the government agency. It is believed that the improper seal caused by the faulty valve can allow the cap to fall off during the surgery or cause an air embolism. 

The FDA has asked for all medical facilities to review their inventory and return unused products affected by the recall to the manufacturer. SterilMed, a subsidiary of Johnson & Johnson, issued a recall for the device on June 12, 2017. They have provided over five million devices to the medical community and specialize in reprocessing and remanufacturing previously owned medical devices. The company was acquired by Johnson and Johnson company Ethicon Endo-Surgery in 2011 according to a press release by J&J. Health care providers are encouraged to monitor patients with the affected devices as normal and can report problems to 1-800-FDA-0178. Consumers and health care providers can also report adverse reactions to the FDA MedWatch program.

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[1]https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm590951.htm

[2] https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm590903.htm

[3] https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm

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