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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Bravo

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  Class 2 Device Recall Medtronic Bravo see related information
Date Initiated by Firm April 28, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 21, 2005
Recall Number Z-0924-04
Recall Event ID 28951
510(K)Number K981733  
Product Classification System, Gastrointestinal Motility (Electrical) - Product Code FFX
Product Medtronic Gastro pH in a Box System, Model 43A008, Catalog Number 9043A0081
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Medtronic Gastroenterology / Urology
4000 Lexington Ave N
Shoreview MN 55126-2917
For Additional Information Contact Ms. Susan A. Frank
763-514-9570
Manufacturer Reason
for Recall		 Inadequate wire insulation inside the plugs of the power cords of the devices may cause the power cords to short.
FDA Determined
Cause 2		 Other
Action Letters dated April 28, 2004 were sent to the consignees. Enclosed with the letter to each consignee were replacement power cord(s). The letters instruct consignees to replace the current power cord by following instructions enclosed with the letter.
Quantity in Commerce 42 units
Distribution The devices were distributed nationwide in the United States.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FFX and Original Applicant = MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
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