Recall Z-1335-2021— Covidien Llc

Name: FDA recall Z-1335-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-26

Class II · Ongoing

Class II FDA medical device recall by Covidien Llc, initiated 2021-02-26. It names one FDA 510(k) clearance: K102543. Product: BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.. Reason: The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the 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 the last 2 years..

Recalling firm: Covidien Llc
Classification: Class II
Status: Ongoing
Initiated: 2021-02-26
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K102543 — BRAVO PH MONITORING SYSTEM AND ACCESSORIESGiven Imaging , Ltd.·cleared 2010-12-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.

Reason for recall

The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the 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 the last 2 years.

Data sourced from openFDA. This site is unofficial and independent of the FDA.