Recall Z-0905-2014— Medtronic Advanced Energy, LLC

Name: FDA recall Z-0905-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-12

Class II · Terminated

Class II FDA medical device recall by Medtronic Advanced Energy, LLC, initiated 2013-11-12, terminated 2014-04-03. It names one FDA 510(k) clearance: K111285. 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.. Reason: 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..

Recalling firm: Medtronic Advanced Energy, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-11-12
Terminated: 2014-04-03
Firm location: Portsmouth, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K111285 — AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTINGSalient Surgical Technologies, Inc.·cleared 2011-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.