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.
What this means for you
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 a theoretical risk to sterility due to process control issues, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the Traj Guide Kit (Catalog No. 9733065, Biopsy, Ext). These are single-use, disposable medical devices distributed nationwide.
The recall was initiated because the company did not have sufficient controls to ensure that returned, unused devices were appropriately examined for product 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 how to return or dispose of the affected units.
The recalled product
- Product
- TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
- 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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