FDA Recalls Given Imaging Bravo pH Capsule Delivery Device
FDA is recalling the Given Imaging Bravo pH capsule delivery device due to a potential allergic reaction risk for patients with nickel sensitivity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (allergic reaction) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Given Imaging Bravo pH capsule delivery device, 1-pack (Item Number: FGS-0313). The device is intended for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The recall is classified as Class II by the FDA.
The recall is being issued because of the potential for an allergic reaction in patients with nickel sensitivity. The source text does not report any specific illnesses, injuries, or deaths associated with this recall. The affected units were distributed worldwide, including the United States (nationwide) and countries such as Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand. The recall covers 1,305 units across all lot numbers.
Consumers and healthcare providers should stop using the device if they have a known sensitivity to nickel. Patients should consult their healthcare provider for alternative monitoring options if necessary.
The recalled product
- 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 c
- Manufacturer
- Covidien LLC
- Affected units
- 1,305
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbrs
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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