Medtronic NDI Passive Spheres Recalled for Reflective Material Variation
Medtronic is recalling NDI Passive Spheres because variation in 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 FDA Class II due to variation in reflective material that may affect the navigation system's ability to detect and track the spheres. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medtronic Navigation, Inc. is recalling Medtronic NDI Passive Spheres (REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly). The recall involves 476,256 units distributed across the United States and several international locations, including the Canary Islands, Iceland, Northern Ireland, Martinique, China, Taiwan, and Hong Kong.
The recall was initiated because the sterile passive spheres and biopsy needle kits contain variation in the reflective material. This variation may affect the ability of the navigation system to detect and track the spheres. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and facilities should stop using the affected products and contact Medtronic Navigation, Inc. for further instructions. The affected lots are identified by specific UDI and lot numbers listed in the official recall documentation.
The recalled product
- Product
- Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 476,256
Distribution
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