The Recall Desk
SevereFDA (Devices)·Z-0905-2014·Announced 2014-02-12

Medtronic Aquamantys3 Pump Generator Recalled for Electrical Safety Defect

Medtronic is recalling 242 Aquamantys3 Pump Generators because internal protection circuitry may fail, exposing patients to DC voltage during surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential electrical shock (DC voltage exposure) to patients during surgery, which constitutes a significant injury risk.

Plain-English summary

Medtronic Advanced Energy, LLC is recalling 242 units of the Aquamantys3 Pump Generator (Catalog Numbers 10-1357 and 40-404-1). The device is a medical instrument that combines radio frequency energy and saline to reduce blood loss during surgical procedures.

The recall is due to a defect in the internal protection circuitry on the electrosurgical output. This circuitry is designed to prevent patients from exposure to DC voltage when the device is activated. The company reports that this protection is being compromised during normal use.

The affected devices were distributed nationwide, including in California, Missouri, Pennsylvania, New Jersey, New York, Ohio, Virginia, Texas, North Carolina, Delaware, Kansas, Tennessee, Louisiana, Illinois, Michigan, South Carolina, Wisconsin, and Florida. The serial numbers for the recalled units range from GN001141 to GN001704 (non-consecutive). Healthcare facilities should contact Medtronic Advanced Energy for instructions on how to return or replace the devices.

The recalled product

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 procedur
Manufacturer
Medtronic Advanced Energy, LLC
Category
Medical Device — Surgical Equipment
Hazard
Affected units
242

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • lowest serial number is GN001141
  • the highest is GN001704 (non-consecutive)

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

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