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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Advanced Energy Aquamantys3 Pump Generator

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 Class 2 Recall
Medtronic Advanced Energy Aquamantys3 Pump Generator
see related information
Date Posted January 31, 2014
Recall Status1 Terminated on April 03, 2014
Recall Number Z-0905-2014
Recall Event ID 66835
Premarket Notification
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, New Hampshire 03801-6837
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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = SALIENT SURGICAL TECHNOLOGIES, INC.
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