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.
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. According to the rubric, FDA Class II recalls with potential for significant injury (such as infection from compromised sterility in a surgical device) are rated as Severe (4).
Plain-English summary
Medtronic Advanced Energy, LLC is recalling Intact Disposable Wands (part of the Intact System), specifically the 777-115BT 5 Pack 15mm Disposable model. 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 involves 499 units with 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 patients should stop using these products and contact Medtronic Advanced Energy, LLC for further instructions or replacement.
The recalled product
- 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…
- Manufacturer
- Medtronic Advanced Energy, LLC
- Affected units
- 499
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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