BEUDAMED
    FDA Recall Terminated

    Given Imaging Bravo pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 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.

    Recall: Z-1620-2016 · Initiated April 15, 2016

    Recall

    Recall Number
    Z-1620-2016
    Event Number
    73882
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    FFT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 15, 2016
    Posted
    May 6, 2016
    Terminated
    July 13, 2017
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Given Imaging Bravo pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 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.

    Reason

    Potential of an allergic reaction in a patient with nickel sensitivity.

    Action

    The firm, Medtronic, sent an "URGENT: Medical Device Recall" letter dated 4/15/2016 to its Customers via Federal Express. The letter describes the product, problem and actions to be taken.The customer was instructed to promptly forward the information from the letter to recipients, if you have distributed any of the affected devices; and complete and return the Acknowledgement and Receipt Form by email to: Quality Compliance [email protected] or Fax to: (203) 492-7719. Medtronic is adding the following statement to the Bravo pH monitoring system User Manual and product package insert so that physicians are aware of the nickel content and the potential of an allergic reaction in a patient with nickel sensitivity. "The Bravo capsule contains a trocar needle that is made of stainless steel. Use caution in patients with known sensitivities or allergies to the metals that are contained including chromium, nickel, copper, cobalt and iron. The Bravo pH test lasts from 48-96 hours." If you have any questions, please contact Technical Service at 1-800-448-3644, option 3.

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand.

    Quantity

    1,305 units