CLASS II Device recall · Reported 8 Feb 2017 · FDA Enforcement Report
Intact Disposable Wands (part of the Intact System) recalled
Medtronic Advanced Energy is recalling Intact Disposable Wands (part of the Intact System) 777-120: Disposable, distributed nationwide in the US. The recall was initiated on 28 Dec 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1134-2017
- FDA event ID
- 76130
- Recalling firm
- Medtronic Advanced Energy, Portsmouth, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Dec 2016
- FDA classified
- 2 Feb 2017
- Reported
- 8 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 28 Dec 2016 | Recall initiated by company | |
| 2 Feb 2017 | Classified by FDA | +36 days |
| 8 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product sterility compromised due to breach of sterile barrier
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Questions about this recall
Is Intact Disposable Wands (part of the Intact System) 777-120: Disposable recalled?
Yes. Medtronic Advanced Energy recalled Intact Disposable Wands (part of the Intact System) 777-120: Disposable on 28 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1134-2017.
Why was it recalled?
Product sterility compromised due to breach of sterile barrier
Which lots are affected?
All lot codes
Where was it sold?
Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Advanced Energy
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intact Disposable Wands (part of the Intact System) recalled | Medtronic Advanced Energy | Sterility | Nationwide |
| Device | CLASS II | Intact Disposable Wands (part of the Intact System) recalled | Medtronic Advanced Energy | Sterility | Nationwide |
| Device | CLASS II | Intact Disposable Wands (part of the Intact System) recalled | Medtronic Advanced Energy | Sterility | Nationwide |
| Device | CLASS II | Intact Disposable Wands (part of the Intact System) recalled | Medtronic Advanced Energy | Sterility | Nationwide |
| Device | CLASS II | Intact Disposable Wands (part of the Intact System) recalled | Medtronic Advanced Energy | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |