FDA Device recall Z-0905-2014
Medtronic Advanced Energy Aquamantys3 Pump Generator
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of Medtronic Advanced Energy Aquamantys3 Pump Generator by Medtronic Advanced Energy, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0905-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-12 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Advanced Energy |
| Distribution | US |
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 procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.
Reason
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.
Identifiers
| code_info | lowest serial number is GN001141; the highest is GN001704 (non-consecutive) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0905-2014%22
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