Agency classClass IIOur severity:Severe FDA (Devices)·Z-1334-2021·Announced 2021-04-07

CF Delivery Dev Caps Bravo x5 Recalled for Aspiration Risk

FDA recalls CF Delivery Dev Caps Bravo x5 capsules because they may fail to attach to the esophagus, leading to aspiration.

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 significant injury, including potential need for intubation and extended hospital stays, which meets the criteria for a Severe rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling CF Delivery Dev Caps Bravo x5 capsules (FGS-0635/FGS 0636) manufactured by Covidien Llc. The recall involves 62,551 units that were distributed worldwide and nationwide in the United States. These devices are intended for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children aged 4 years and older.

The recall is due to a risk that the capsule may fail to attach to the esophageal mucosa. If the capsule detaches, it may be aspirated into the airway. In such cases, immediate intervention is required to remove the capsule. Potential outcomes of 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 in the last two years.

Patients and healthcare providers should stop using the affected capsules and contact their healthcare provider for guidance on removal or replacement. Consumers should check their lot numbers against the list provided in the official recall notice to determine if their devices are affected.

The recalled product

Product: CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - 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