Reported Feb 12, 2014 · Terminated
Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as…
Medtronic Advanced Energy, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Advanced Energy, LLC · 180 International Dr · Portsmouth, NH · 03801-6837
Is this the product you have?
- Medtronic Advanced Energy Aquamantys3 Pump Generator
- Product Catalog Number10-1357 (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
- Lot codes and dates
lowest serial number is GN001141the highest is GN001704 (non-consecutive)
- Amount recalled
- 242 devices
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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