Medtronic Advanced Energy Aquamantys3 Pump Generator — Class II medical device recall Z-0905-2014
Terminated recall by Medtronic Advanced Energy, LLC, reported 2014-02-12, distributed nationwide. The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC vo
| Recall number | Z-0905-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Advanced Energy, LLC, Portsmouth, NH, United States |
| Recall initiated | 2013-11-12 |
| Classified | 2014-01-31 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 242 devices |
| Serial numbers | GN001141 |
| Model numbers | 10-1357 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0905-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.