Medtronic Ascenda Intrathecal Catheter Kit Recalled for Labeling Errors
Medtronic is voluntarily removing a single Ascenda Intrathecal Catheter kit due to incorrect outer package labels that may result in missing components.
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, but the source explicitly states it is a voluntary removal due to labeling errors with no reported injuries or illnesses, fitting the 'voluntary precautionary recalls' and 'minor labeling errors' criteria for a Moderate score.
Plain-English summary
Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda Intrathecal Catheter kit. The recall is limited to one specific unit identified by code N558983006.
The company identified that this specific kit may have been produced with incorrect outer package labels. As a result of this labeling error, the kit may not contain all the components necessary to complete the implant procedure.
The affected product was distributed internationally to Japan. Medtronic states that 9 units were involved in the distribution, with 1 unit still unused. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
- Manufacturer
- Medtronic Neuromodulation
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)
- N558983006
Distribution
Distribution scope not specified by the agency.
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