Class 2 Device Recall Medtronic Advanced Energy Aquamantys3 Pump Generator

• Date Initiated by Firm: November 12, 2013
• Date Posted: January 31, 2014
• Recall Status: Terminated on April 03, 2014
• Recall Number: Z-0905-2014
• Recall Event ID: 66835
• 510(K)Number: K111285
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.
• Code Information: lowest serial number is GN001141; the highest is GN001704 (non-consecutive)
• Recalling Firm/ Manufacturer: Medtronic Advanced Energy, LLC; 180 International Dr; Portsmouth NH 03801-6837
• For Additional Information Contact: 866-777-9400
• Manufacturer Reason for Recall: The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use.
• FDA Determined Cause: Device Design
• Action: Medtronic sent an Urgent Product Removal Notification on November 12, 2013, via Next Day FEDEX. The communication advises users to immediately stop using the affected AQM3 electrosurgical generators and quarantine them until they can be returned to Medtronic Advanced Energy. Medtronic field personnel will collect them in order to remove them from service and return them to Medtronic Advanced Energy. Customers with questions were instructed to contact Customer Service at 866-777-9400. For questions regarding this recall call 866-777-9400.
• Quantity in Commerce: 242 devices
• Distribution: Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
• 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 = GEI