Manufacturer

Medtronic Advanced Energy, LLC

12 recalls in our database name Medtronic Advanced Energy, LLC as the manufacturing or recalling firm.

What the numbers show

Total: 12
Critical: 0
Severe: 5
Most recent: 2017-02-08

Of the 12 recalls from Medtronic Advanced Energy, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (42%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

SevereFDA (Devices)·Z-1136-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling 105 Intact Disposable Wands because the sterile barrier was breached, compromising product sterility.
Product
Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm 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 br
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1132-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall affects 499 units distributed worldwide.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1133-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 275 units distributed worldwide.
Product
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 br
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1126-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising product sterility. The recall affects units distributed worldwide.
Product
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 br
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising product sterility.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1129-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling 252 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The devices are used for breast tissue removal.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1130-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling 185 units of Intact Disposable Wands because the sterile barrier was breached, compromising sterility.
Product
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 br
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1127-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 155 units distributed worldwide.
Product
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 br
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1131-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 320 units distributed worldwide.
Product
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 br
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1134-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling 326 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers units distributed in the US and several international countries.
Product
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 br
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall affects 180 units distributed worldwide.
Product
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 br
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0905-2014·2014-02-12
Medtronic Aquamantys3 Pump Generator Recalled for Electrical Safety Defect
Medtronic is recalling 242 Aquamantys3 Pump Generators because internal protection circuitry may fail, exposing patients to DC voltage during surgery.
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 procedur
Category
Medical Device
Distribution
Distributed nationwide