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Bravo™ - capsule delivery sys

Official notice

5 Jun 2025

Last checked

5 Jun 2025

High riskHealth Canada

An official Health Canada notice concerns Bravo™ - capsule delivery sys. Medtronic noted an increase in the number and rate of serious injuries during use of the Bravo™ CF Capsule delivery reported between January 2025 and April 2025. The increased number and rate of serious injuries may be attributed to the device's malfunction due to misapplied adhesive. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device. Recall start date: June 3, 2025 Published 2025-06-05.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77560

Official notice

2025-06-05

The hazard

Medtronic noted an increase in the number and rate of serious injuries during use of the Bravo™ CF Capsule delivery reported between January 2025 and April 2025. The increased number and rate of serious injuries may be attributed to the device's malfunction due to misapplied adhesive. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device. Recall start date: June 3, 2025

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77560

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Affected products

Product 1

Affected products - Bravo™ - Capsule Delivery Sys, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - FGS-0635

Risk / hazard

Medtronic noted an increase in the number and rate of serious injuries during use of the Bravo™ CF Capsule delivery reported between January 2025 and April 2025. The increased number and rate of serious injuries may be attributed to the device's malfunction due to misapplied adhesive. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device. Recall start date: June 3, 2025

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Given Imaging, Bravo™ - Capsule Delivery Sys.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type I

App estimate

high

Recall details

Recall number

77560

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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