Class 2 Device Recall Bravo pH and CF Capsule

• Date Initiated by Firm: February 26, 2021
• Create Date: April 01, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1335-2021
• Recall Event ID: 87396
• 510(K)Number: K102543
• Product Classification: Electrode, pH, stomach - Product Code FFT
• 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.
• Code Information: 49349Q 49350Q 49351Q 49352Q 49799Q 49800Q 49801Q 49802Q 49809Q 49849Q 49850Q 49851Q 50392Q 50393Q 50492Q 50493Q 50494Q 50495Q 50496Q 50497Q 50615Q 50616Q 50868Q 50869Q 50870Q 50871Q 50872Q 50873Q 50874Q 50875Q 50876Q 50877Q 50878Q 50879Q 50880Q 50881Q
• Recalling Firm/ Manufacturer: Covidien Llc; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: Customer Service; 800-448-3644
• Manufacturer 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.
• FDA Determined Cause: Process change control
• Action: 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.
• Quantity in Commerce: 62551
• Distribution: Worldwide distribution - US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FFT and Original Applicant = GIVEN IMAGING LTD.