Recall Z-0905-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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 o
| Date | Jan 31, 2014 (initiated Nov 12, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111285 | AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING Salient Surgical Technologies, Inc., Sep 9, 2011 |