FDA Medical Device Recalls (openFDA)
Medtronic Advanced Energy, LLC: 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.
- Recall number
- Z-0905-2014
- Recalling firm
- Medtronic Advanced Energy, LLC
- 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.
- Status
- Terminated
- Initiated
- 2013-11-12
- Posted
- 2014-01-31
- Terminated
- 2014-04-03
- 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.
- Root cause
- Device Design
- Action
- Medtronic sent an Urgent Product Removal Notification on November 12, 2013, via Next Day FEDEX. The communication advises users to immediately stop using the affected AQM3 electrosurgical generators and quarantine them until they can be returned to Medtronic Advanced Energy. Medtronic field personnel will collect them in order to remove them from service and return them to Medtronic Advanced Energy. Customers with questions were instructed to contact Customer Service at 866-777-9400. For questions regarding this recall call 866-777-9400.
- Quantity
- 242 devices
- Distribution
- Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
- Lot, serial or model codes
- lowest serial number is GN001141; the highest is GN001704 (non-consecutive)
- 510(k) numbers
- ["K111285"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000517638
- Firm city
- Portsmouth
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28