FDA (Devices) recall action 76130

Medtronic Advanced Energy, LLC recalled 11 products on 2017-02-08

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2017-02-08
Critical: 0
Units: 3,303

Why these products were recalled

Product sterility compromised due to breach of sterile barrier

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

SevereFDA (Devices)··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
Distribution
0 states
HighFDA (Devices)··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
Distribution
0 states
HighFDA (Devices)··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
Distribution
0 states
SevereFDA (Devices)··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
Distribution
0 states
HighFDA (Devices)··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
Distribution
0 states
SevereFDA (Devices)··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
Distribution
0 states
HighFDA (Devices)··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
Distribution
0 states
HighFDA (Devices)··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
Distribution
0 states
SevereFDA (Devices)··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
Distribution
0 states
HighFDA (Devices)··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
Distribution
0 states
HighFDA (Devices)··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
Distribution
0 states