Agency classClass IIOur severity:Severe FDA (Devices)·Z-1335-2021·Announced 2021-04-07

FDA Recalls Bravo pH Capsule Delivery Devices Due to Aspiration Risk

The FDA is recalling Bravo pH Capsule Delivery Devices because the capsule may fail to attach to the esophagus, leading to aspiration and potential hospitalization.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves reports of hospitalization and significant injury (aspiration requiring intubation), which meets the criteria for a Severe rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling the Bravo pH Capsule Delivery Device (FGS-0312/FGS-0313) manufactured by Covidien LLC. The device is intended for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children aged 4 years and older. The recall affects 62,551 units distributed worldwide and nationwide in the United States.

The recall is being issued because the capsule may fail to attach to the esophageal mucosa. This failure can lead to the aspiration of the capsule, which requires immediate intervention to remove it. Potential outcomes of capsule aspiration include low oxygen saturation, the need for intubation, extended hospital stays, and delays in treatment. The FDA has received 13 reports of capsule aspiration over the last two years.

Consumers and healthcare providers should stop using the affected devices and contact the manufacturer or their healthcare provider for instructions on how to proceed. The recall is classified as Class II, indicating a reasonable probability that the device's use may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
Manufacturer: Covidien Llc
Category: Medical Device — Gastroenterology
Hazard: aspiration
device-failure
Affected units: 62,551

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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Same hazard · aspiration