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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: lowest serial number is GN001141; the highest is GN001704 (non-consecutive)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Advanced Energy, LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
lowest serial number is GN001141; the highest is GN001704 (non-consecutive)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0905-2014
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