Z-0905-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2014
- Initiation Date
- November 12, 2013
- Termination Date
- April 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 242 devices
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.
Distribution Pattern
Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
Code Information
lowest serial number is GN001141; the highest is GN001704 (non-consecutive)