Medtronic NDI Passive Spheres Recalled for Reflective Material Variation
Medtronic is recalling NDI Passive Spheres and biopsy needle kits because reflective material variation 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 14,210 units of Medtronic NDI Passive Spheres (REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly) and biopsy needle kits. 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 in the United States and several international locations, including the Canary Islands, Iceland, Northern Ireland, Martinique, China, Taiwan, and Hong Kong.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers should stop using the affected products and contact Medtronic Navigation, Inc. for further instructions.
The recalled product
- Product
- Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 14,210
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: 20805832070016/ Lot codes: 2506331 2506571 2510111 2510511 2511091
Distribution
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