Agency classClass IIOur severity:High FDA (Devices)·Z-1619-2016·Announced 2016-05-18

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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…
Manufacturer: Covidien LLC
Category: Medical Device — Diagnostic Device
Hazard: allergic-reaction
nickel-sensitivity
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.

See all 2 products in this recall →

Same manufacturer · Covidien LLC

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