Medtronic Recalls Traj Guide Kits Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected 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 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 illnesses, injuries, or hospitalizations. The hazard is theoretical (potential sterility compromise due to lack of inspection), which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the Traj Guide Kit (Catalog No. 9733066, Biopsy, Int). These are single-use, disposable medical devices distributed nationwide.
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 inspection could potentially compromise the sterility of the devices.
Consumers and healthcare facilities should stop using these devices and contact Medtronic Navigation for further instructions on return or replacement.
The recalled product
- Product
- TRAJ GUIDE KIT, 9733066, BIOPSY, INT
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 26,674
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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