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.
FDA Recall Z-0905-2014 · Posted 2014-01-31
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Recalling FirmMedtronic Advanced Energy, LLC
Recall StatusTerminated
Product CodeGEI
Date Initiated2013-11-12
Date Terminated2014-04-03
Product Quantity242 devices
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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