BEUDAMED
    FDA Enforcement Class II Ongoing

    BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.

    Recall: Z-1335-2021 · Reported April 7, 2021

    Enforcement

    Recall Number
    Z-1335-2021
    Event ID
    87396
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 7, 2021
    Initiation Date
    February 26, 2021
    Classification Date
    April 1, 2021
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113, United States

    Description

    BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.

    Reason

    The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.

    Code Info

    49349Q 49350Q 49351Q 49352Q 49799Q 49800Q 49801Q 49802Q 49809Q 49849Q 49850Q 49851Q 50392Q 50393Q 50492Q 50493Q 50494Q 50495Q 50496Q 50497Q 50615Q 50616Q 50868Q 50869Q 50870Q 50871Q 50872Q 50873Q 50874Q 50875Q 50876Q 50877Q 50878Q 50879Q 50880Q 50881Q

    Distribution

    Worldwide distribution - US Nationwide distribution.

    Quantity

    62551