Medtronic Advanced Energy, LLC: Medical Device Recall in 2014 - (Recall #: Z-0905-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 12, 2013

Date Posted: February 12, 2014

Recall Number: Z-0905-2014

Event ID: 66835

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.

Status: Terminated

Product Quantity: 242 devices

Code Information:

lowest serial number is GN001141; the highest is GN001704 (non-consecutive)

Distribution Pattern:

Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.

Voluntary or Mandated:

Voluntary: Firm initiated