Z-0905-2014Class II

Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly)...

Name: Z-0905-2014 Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly)...
Creator: Medtronic Advanced Energy, LLC
Published: 2013-11-12
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2013-11-12 / Terminated / root cause: design

FDA source

Medtronic Advanced Energy, LLC began a recall of Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The... on 2013-11-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0905-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-12
Posted: 2014-01-31
Terminated: 2014-04-03
Recalling firm: Medtronic Navigation, Inc
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: design
FDA root 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.
Product codes and lots: lowest serial number is GN001141; the highest is GN001704 (non-consecutive)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0905-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0905-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-01-31

Product code GEI

K111285Class IIAquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with CuttingSalient Surgical Technologies, Inc. / cleared 2011-09-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)