Bravo reflux capsule and calibration-free reflux capsules (2021-03-03)

Starting date:

March 25, 2021

Posting date:

March 25, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-75195

Last updated:
2021-03-25

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  Reason
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  Affected products

Affected Products

Bravo reflux capsule and calibration-free reflux capsules

Reason

This voluntary recall is being conducted following customer reports of the Bravo Reflux Capsule failing to attach to the esophageal mucosa. In cases where the capsule fails to attach to the esophageal mucosa, the potential exists for aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received in the last 2 years. Manufacturing process improvements have been implemented to address this issue.

Affected products