Public recall detail

Bravo - Capsule Delivery System

2026-08-07

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Health products Health product recall
Quick summary

Quick summary: Bravo - Capsule Delivery System. Reason: Health product recall. Category: Health products. Date: 2026-08-07.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Bravo - Capsule Delivery System. Reason: Health product recall. Category: Health products. Date: 2026-08-07.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandGiven Imaging, Inc.
ProductBravo - Capsule Delivery System
IssueMedical devices - Performance
Recall classType I
IdentificationRA-82460

Affected products

ProductBravo - Capsule Delivery Sys
LotMore than 10 numbers, contact manufacturer.
ModelFGS-0635
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionBravo - Capsule Delivery Sys

Issue

Medtronic has identified an increase in complaints involving the Bravo CF capsule delivery device where the capsule fails to attach to the esophagus or detach from the delivery device. Medtronic's preliminary root cause investigation has identified a potential condition impacting the component that controls the deployment of the capsule which can then be exacerbated by a failure to keep the delivery device straight as instructed in the user guide, as a potential cause. Risks associated with this issue include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.Lots with an expiration date of December 10, 2027, or later are not in scope of this recall and do not need to be returned.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesGiven Imaging, Inc.15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
Recall date2026-08-06
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-82460
Background{}
CompaniesGiven Imaging, Inc.15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
AudiencesHealthcare
Source updated2026-08-07

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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