Class 2 Device Recall Medtronic Bravo

• Date Initiated by Firm: April 28, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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
• FEI Number: 1000135098
• 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: 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