Recall MonitorHealth ProductsType I recall
Bravo™ - Capsule Delivery Sys
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: Bravo™ - Capsule Delivery Sys
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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