Medtronic Recalls AxiEM Tumor Resonance Packs Due to Sterility Concerns
Medtronic Navigation is recalling 26,674 AxiEM Tumor Resonance Packs because returned devices may not have been properly examined for damage to ensure sterility.
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 text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential sterility issue due to a process control failure, which fits the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the TUMOR RES. PACK 9733553 AxiEM S.M. These are single-use, disposable medical devices distributed nationwide. The recall affects Lot No. 6402019 and 6402024.
The recall was initiated because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. This lack of control raises concerns about the ability to ensure the sterility of the devices.
Healthcare providers and facilities should stop using these specific lots and follow the instructions provided by Medtronic Navigation for the return or disposal of the affected devices.
The recalled product
- Product
- TUMOR RES. PACK 9733553 AxiEM S.M.
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 26,674
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)
- Lot No.: 6402019 6402024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Medtronic Navigation, Inc. 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.
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