2016-05-17 12:40:15 UTC

FDA Recalls Bravo pH Capsule Delivery Device

May 17, 2016

Recall aims to prevent potential allergic reactions in patients.

FDA issued Class II device recalls on May 6, 2016, for the Bravo pH capsule delivery device, five-pack, and the Bravo pH capsule delivery device, one-pack. The listed reason for the recalls is "potential of an allergic reaction in a patient with nickel sensitivity."

The Bravo pH Monitoring System is intended for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from four years of age  The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view and analyze gastroesophageal pH data.

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