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.
Recall
- Recall Number
- Z-1335-2021
- Event Number
- 87396
- Firm
- Covidien Llc
- FEI Number
- 1282497
- Product Code
- FFT
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- February 26, 2021
- Address
- 15 Hampshire St, Mansfield, MA, 02048-1113
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.
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.
On February 26, 2021, the firm initiated mailing of Urgent Medical Device Recall letters to affected customers. Customers were advised that 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. Customers were asked to do the following: 1. Please immediately quarantine and discontinue use of affected item codes and lots. 2. Please return affected product as indicated in the letter. All unused products from the affected item codes and lots must be returned. 3. If you have distributed the affected Bravo capsules, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-448-3644, option 2, option 2.
Worldwide distribution - US Nationwide distribution.
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