—#145297

Product

Given Imaging Bravo pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 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.

FDA product code: FFT — Electrode, Ph, Stomach
Device class: Class 1
Medical specialty: Gastroenterology, Urology
510(k) numbers: K002028
Affected lot / code info: All lot numbers

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-04-15
Posted by FDA: 2016-05-06
Terminated: 2017-07-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145297. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.