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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility is compromised, posing a risk of infection. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not classified as FDA Class I.
Plain-English summary
Medtronic Advanced Energy, LLC is recalling 155 units of Intact Disposable Wands (part of the Intact System), catalog number 900-112. These 12mm 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.
The recall was initiated because the product sterility was compromised due to a breach of the sterile barrier. The affected units were distributed worldwide, including in the United States, China, Greece, the Netherlands, Egypt, Turkey, and Switzerland. The recall applies to all lot codes.
Healthcare providers and patients who have used or possess these wands should contact Medtronic Advanced Energy, LLC for further instructions on how to proceed. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- 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…
- Manufacturer
- Medtronic Advanced Energy, LLC
- Affected units
- 155
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Medtronic Advanced Energy, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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See all →- HighMedtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08
- HighMedtronic Intact Disposable Wands Recalled for Sterility Compromise
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- HighMedtronic Intact Disposable Wands Recalled for Sterility Compromise
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- SevereMedtronic Intact Disposable Wands Recalled Due to Sterility Compromise
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- HighMedtronic Intact Disposable Wands Recalled for Sterility Compromise
FDA (Devices) · 2017-02-08
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