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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. A breach of the sterile barrier in a medical device used for tissue removal poses a significant risk of infection, which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Medtronic Advanced Energy, LLC is recalling Intact Disposable Wands (part of the Intact System), catalog number 777-110, 5 Pack 10mm Disposable. The recall is due to a breach of the sterile barrier, which compromises the sterility of the product. These 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 includes 10 units from all lot codes. The products were distributed worldwide, including US Nationwide and in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.
Healthcare providers and facilities should stop using the affected Intact Disposable Wands immediately. Users should contact Medtronic Advanced Energy, LLC for further instructions on how to return or dispose of the recalled products.
The recalled product
- 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…
- Manufacturer
- Medtronic Advanced Energy, LLC
- Affected units
- 10
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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