Health product recall

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

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

Bravo reflux capsule and calibration-free reflux capsules

Lot or serial number

Lot# 48085F
Lot# 48759Q
Lot# 48763Q
Lot# 49349Q
Lot# 49809Q
Lot# 50848F

Model or catalog number

FGS-0312
FGS-0635

Companies
Manufacturer

GIVEN IMAGING INC,

15 Hampshire Street

Mansfield

02048

Massachusetts

UNITED STATES