Medtronic Advanced Energy
Country not established
- Devices
- 11
- FDA recalls
- 12
At a glance
Market reach
- United States
- FDA recalls
What Medtronic Advanced Energy makes
Medtronic Advanced Energy manufactures plasma-based surgical devices, including the PlasmaBlade series for precise tissue dissection and coagulation, such as the PlasmaBlade T, PlasmaBlade UPPP, and PlasmaBlade X variants. Their portfolio also includes the CoreCath 2.7S for cardiac procedures and the Minimally Invasive Sealer (MIS) Flex and Mini for soft tissue sealing. Additionally, they produce the AEx Generator, which powers plasma-based surgical tools, and the Medtronic Total Hip Arthroplasty System for joint replacement surgery.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 11 devicesFDA recalls
FDA recall records list 12 recalls initiated by Medtronic Advanced Energy, the earliest on 2013-11-12 and the most recent on 2016-12-28. By recorded status: 12 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 28 Dec 2016 Z-1126-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
- 28 Dec 2016 Z-1127-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
- 28 Dec 2016 Z-1128-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
- 28 Dec 2016 Z-1129-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
- 28 Dec 2016 Z-1130-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
- 28 Dec 2016 Z-1131-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
- 28 Dec 2016 Z-1132-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
- 28 Dec 2016 Z-1133-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
- 28 Dec 2016 Z-1134-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
- 28 Dec 2016 Z-1135-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
Show all 12 recalls
2016
- 28 Dec 2016 Z-1136-2017 Class II Terminated Product sterility compromised due to breach of sterile barrier
2013
- 12 Nov 2013 Z-0905-2014 Class II Terminated 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.
Frequently asked questions
How many devices does Medtronic Advanced Energy have in the registry?
The registry currently lists 11 devices for Medtronic Advanced Energy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Advanced Energy's devices?
Among its 11 most recently registered devices, Medtronic Advanced Energy has devices listed in FDA 510(k) (11 devices).
What risk classes do Medtronic Advanced Energy's devices fall under?
Among its 11 most recently registered devices, the classes recorded for Medtronic Advanced Energy's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medtronic Advanced Energy?
FDA recall records list 12 recalls initiated by Medtronic Advanced Energy, the most recent initiated on 28 Dec 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medtronic Advanced Energy in the registry?
The most recently registered devices listed for Medtronic Advanced Energy include PlasmaBlade T, AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER, PlasmaBlade UPPP and Suction Coagulator and CoreCath 2.7S.