FDAFDA · Food and drugs·Recall number Z-0905-2014
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.
Published February 12, 2014 · Recall initiated: November 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Advanced Energy, LLC
- Distributor
- Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
- Lot
- lowest serial number is GN001141; the highest is GN001704 (non-consecutive)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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