Medtronic Recalls ENT Navigation Devices Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 ENT PRGM 9734636 ADD FUSION NAV AxiEM devices because returned units 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. The hazard involves a potential sterility issue due to inadequate inspection of returned devices, which is a significant quality control failure but does not involve reported injuries or deaths, fitting the Moderate criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the ENT PRGM 9734636 ADD FUSION NAV AxiEM. These are single-use, disposable medical devices distributed nationwide. The specific lot number for the recalled items is 6917614.
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 that have received these devices should stop using them and contact Medtronic Navigation for instructions on how to return or dispose of the products. Consumers are not expected to have these professional medical devices in their homes.
The recalled product
- Product
- ENT PRGM 9734636 ADD FUSION NAV AxiEM
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — ENT Navigation
- Hazard
- 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.: 6917614
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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