Recall of Given Imaging Bravo pH Capsule Delivery Devices
Covidien LLC is recalling Bravo pH capsule delivery devices due to a potential risk of allergic reactions in 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 is classified as FDA Class II and involves a risk of allergic reaction (harm) in a specific patient population (nickel sensitivity), but the source text does not report any actual illnesses, injuries, or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Given Imaging Bravo pH capsule delivery device, 5-pack (Item Number: FGS-0312). The recall involves 12,895 units distributed nationwide in the United States and in 15 other countries, including Argentina, Australia, Belgium, Brazil, Canada, Cyprus, El Salvador, Greece, Hong Kong, Israel, Mexico, Panama, Singapore, South Korea, and Thailand. All lot numbers are affected.
The recall is being conducted because of the potential for an allergic reaction in patients with nickel sensitivity. The Bravo pH Monitoring System is an in-vitro diagnostic device intended for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The device is typically attached following endoscopy or manometry.
Consumers and healthcare providers should stop using the recalled devices and contact their healthcare provider or the manufacturer for further instructions. The recall is voluntary and is classified as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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 chi
- Manufacturer
- Covidien LLC
- Affected units
- 12,895
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 numbers
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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