Z-1620-2016Class II

Given Imaging Bravo pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric...

Name: Z-1620-2016 Given Imaging Bravo pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric...
Creator: Covidien LLC
Published: 2016-04-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-04-15 / Terminated / root cause: design

FDA source

Covidien LLC began a recall of 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... on 2016-04-15. FDA classified it as Class II and gives the reason as "Potential of an allergic reaction in a patient with nickel sensitivity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1620-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Posted: 2016-05-06
Terminated: 2017-07-13
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: FFT Electrode, Ph, Stomach
Reason for recall: Potential of an allergic reaction in a patient with nickel sensitivity.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 1,305 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 Thailand.
Product codes and lots: All lot numbrs

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1620-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1619-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-06
Z-1620-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-06

Product code FFT

K002028Class IBravo Ph Monitoring SystemEndonetics, Inc. / cleared 2000-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)