Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as
FDA device recall Z-0905-2014 · posted 2014-01-31 · Terminated
Recall details
- Recalling firm
- Medtronic Advanced Energy, LLC
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 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.
- Date initiated
- 2013-11-12
- Date posted
- 2014-01-31
- Date terminated
- 2014-04-03
- Location
- Portsmouth, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING (K111285) | Salient Surgical Technologies, Inc. | 2011-09-09 |