Medtronic Recalls Single-Use Navigation Devices Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 single-use, disposable navigation devices because returned units were not adequately examined for damage that could compromise 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility cannot be assured due to lack of inspection for damage, representing a risk of harm (infection) where injury has not yet been reported.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 single-use, disposable devices identified as UPGRD PRGM 9734638 ADD AxiEM NAVIGATION. The recall is due to insufficient controls to ensure that returned, unused devices were appropriately examined for product and/or package damage, which is necessary to verify sterility.
The affected devices were distributed nationwide. The specific lot number associated with this recall is 6148186.
Consumers and healthcare providers should stop using these devices and contact Medtronic Navigation for instructions on how to return or dispose of them.
The recalled product
- Product
- UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — Navigation
- 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.: 6148186
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.
See all 25 products in this recall →Related recalls
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