CLASS II Device recall · Reported 18 May 2016 · FDA Enforcement Report
Given Imaging Bravo¿ pH capsule delivery device In-Vitro recalled
Covidien is recalling Given Imaging Bravo¿ pH capsule delivery device In-Vitro Diagnostic for pH monitoring of, distributed nationwide in the US. The recall was initiated on 15 Apr 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1619-2016
- FDA event ID
- 73882
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Apr 2016
- FDA classified
- 6 May 2016
- Reported
- 18 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 15 Apr 2016 | Recall initiated by company | |
| 6 May 2016 | Classified by FDA | +21 days |
| 18 May 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential of an allergic reaction in a patient with nickel sensitivity.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is Given Imaging Bravo¿ pH capsule delivery device In-Vitro Diagnostic for pH monitoring of recalled?
Yes. Covidien recalled Given Imaging Bravo¿ pH capsule delivery device In-Vitro Diagnostic for pH monitoring of on 15 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1619-2016.
Why was it recalled?
Potential of an allergic reaction in a patient with nickel sensitivity.
Which lots are affected?
All lot numbers
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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