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U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic Bravo

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 Class 3 Device Recall Medtronic Bravosee related information
Date Initiated by FirmFebruary 06, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on November 21, 2005
Recall NumberZ-0633-04
Recall Event ID 28253
510(K)NumberK002028 
Product Classification Probe And Director, Gastro-Urology - Product Code FGM
ProductBravo pH Monitoring System Receiver
Code Information All serial numbers less than 400,000 are involved.
FEI Number 1000135098
Recalling Firm/
Manufacturer		 Medtronic Gastroenterology / Urology
4000 Lexington Ave N
Shoreview MN 55126-2917
For Additional Information ContactSusan A. Frank
763-514-9570
Manufacturer Reason
for Recall		The product's rear panel label could smear during use causing the serial number to be unreadible. This has the remote possibility of resulting in patient data from diagnostic tests being mixed-up or attributed to the wrong patient.
FDA Determined
Cause 2		Other
ActionLetters dated February 6, 2004 were sent to the consignees. Enclosed with the letter to each consignee were label sticker(s) having the serial numbers of the device(s) purchased by the consignee. The letters instruct consignees to place the enclosed stickers on the devices over the previous back panel labels if the serial number of the label matches the serial number on the device. Special instructions for devices with smeared labels include the return of devices with unreadable serial numbers.
Quantity in Commerce1468 units
DistributionThe devices were distributed nationwide in the United States and worldwide.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FGM
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