Medtronic Advanced Energy, LLC
FDA adverse event reports naming Medtronic Advanced Energy, LLC as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDTRONIC ADVANCED ENERGY, LLC.
- Total reports
- 1,410
- Deaths
- 13
- Injuries
- 429
- Malfunctions
- 966
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI984
- Electrosurgical DeviceDWG202
- Generator, Electrosurgical, Coagulation, CancerMUL127
- Instrument, BiopsyKNW63
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH26
- Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE4
- Product code ------1
- RetractorGAD1
- Laparoscope, General & Plastic SurgeryGCJ1
- Rongeur, ManualHAE1
Recent recalls
- 2017-02-02TerminatedPackage design/selection
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
- 2017-02-02TerminatedPackage design/selection
Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
- 2017-02-02TerminatedPackage design/selection
Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
- 2017-02-02TerminatedPackage design/selection
Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
- 2017-02-02TerminatedPackage design/selection
Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
- 2017-02-02TerminatedPackage design/selection
Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
- 2017-02-02TerminatedPackage design/selection
Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
- 2017-02-02TerminatedPackage design/selection
Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
- 2017-02-02TerminatedPackage design/selection
Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
- 2017-02-02TerminatedPackage design/selection
Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.
Product sterility compromised due to breach of sterile barrier
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