Given Imaging Bravo pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Num

FDA device recall Z-1619-2016 · posted 2016-05-06 · Terminated

Recall details

Recalling firm

Covidien LLC

Reason for recall

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

Action taken

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 MITGFCA@Covidien.com 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.

Root cause

Device Design

Status

Terminated

Product code

FFT

Quantity affected

12,895 units

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 Tha

Date initiated

2016-04-15

Date posted

2016-05-06

Date terminated

2017-07-13

Location

North Haven, CT

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