CLASS II Device recall · Reported 12 Feb 2014 · FDA Enforcement Report
Aquamantys3 Pump Generator recalled by Medtronic Advanced Energy
Medtronic Advanced Energy is recalling Aquamantys3 Pump Generator, distributed nationwide in the US. The recall was initiated on 12 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0905-2014
- FDA event ID
- 66835
- Recalling firm
- Medtronic Advanced Energy, Portsmouth, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2013
- FDA classified
- 31 Jan 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 12 Nov 2013 | Recall initiated by company | |
| 31 Jan 2014 | Classified by FDA | +80 days |
| 12 Feb 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
Nationwide CaliforniaDelawareFloridaIllinoisKansasLouisianaMichiganMissouriNorth CarolinaNew JerseyNew YorkOhioPennsylvaniaSouth CarolinaTennesseeTexasVirginiaWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
lowest serial number is GN001141; the highest is GN001704 (non-consecutive)
Where was it sold?
Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Advanced Energy
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intact Disposable Wands (part of the Intact System) recalled | Medtronic Advanced Energy | Sterility | Nationwide |
| Device | CLASS II | Intact Disposable Wands (part of the Intact System) recalled | Medtronic Advanced Energy | Sterility | Nationwide |
| Device | CLASS II | Intact Disposable Wands (part of the Intact System) recalled | Medtronic Advanced Energy | Sterility | Nationwide |
| Device | CLASS II | Intact Disposable Wands (part of the Intact System) recalled | Medtronic Advanced Energy | Sterility | Nationwide |
| Device | CLASS II | Intact Disposable Wands (part of the Intact System) recalled | Medtronic Advanced Energy | Sterility | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |