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U.S. Department of Health and Human Services

Class 2 Device Recall Bravo pH and CF Capsule

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  Class 2 Device Recall Bravo pH and CF Capsule see related information
Date Initiated by Firm February 26, 2021
Create Date April 01, 2021
Recall Status1 Open3, Classified
Recall Number Z-1334-2021
Recall Event ID 87396
510(K)Number K102543  
Product Classification Electrode, pH, stomach - Product Code FFT
Product CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - 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 46966F 47358F 47359F 47360F 47361F 47362F 47363F 47364F 47365F 47366F 47367F 47368F 47369F 47370F 47371F 47783F 48082F 48083F 48084F 48085F 48086F 48087F 48088F 48090F 48091F 48092F 48437F 48438F 48439F 48440F 48441F 48442F 48443F 48444F 48445F 48446F 48447F 48448F 48449F 48781F 48782F 48783F 49068F 49069F 49070F 49071F 49072F 49073F 49074F 49075F 49076F 49077F 49078F 49079F 49080F 49081F 49082F 49083F 49084F 49366F 49367F 49368F 49369F 49370F 49371F 49372F 49373F 49374F 49375F 49376F 49377F 49378F 49379F 49380F 49381F 49382F 49383F 49384F 49385F 49386F 49387F 49388F 49663F 49664F 49665F 49666F 49667F 49668F 49911F 49912F 49913F 49914F 50197F 50198F 50199F 50285F 50286F 50287F 50297F 50298F 50299F 50300F 50301F 50370F 50371F 50372F 50374F 50375F 50376F 50377F 50378F 50379F 50380F 50489F 50490F 50595F 50596F 50597F 50598F 50599F 50600F 50601F 50602F 50603F 50604F 50605F 50606F 50607F 50608F 50609F 50610F 50848F 50849F 50850F 50851F 50852F 50853F 50854F 51184F 51185F 51186F 51187F 51188F 51190F 
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 2		 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 62,551
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.
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