Bravo™ - Capsule Delivery Sys
Brand(s)
Last updated
Summary
Product
Bravo™ - Capsule Delivery Sys
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Bravo™ - Capsule Delivery Sys | More than 10 numbers, contact manufacturer. | FGS-0635 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Given Imaging, Inc.
15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-77560
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