Medtronic Biopsy Needle Kit Recalled for Reflective Material Variation
Medtronic is recalling 3,746 Biopsy Needle Kits because variation in the reflective material may affect the navigation system's ability to detect and track the spheres.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II, and the source describes a functional defect where reflective material variation may affect the navigation system's ability to detect and track spheres. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic Navigation, Inc. is recalling 3,746 units of the Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly. The recall is due to variation in the reflective material contained in the sterile passive spheres and biopsy needle kits.
This variation may affect the ability of the navigation system to detect and track the spheres. The affected products were distributed to various US states and territories, as well as international locations including the Canary Islands, Iceland, Northern Ireland, Martinique, China, Taiwan, and Hong Kong.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses, injuries, or deaths associated with the use of these products.
The recalled product
- Product
- Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- Affected units
- 3,746
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)
- UDI:00643169030121/Lots: 066500526 066506326
Distribution
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