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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- 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.
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