Medtronic Recalls Tumor Resection Kits Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 Tumor Resection Kits 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 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 risk-of-harm product (sterility failure of a medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Navigation, Inc. is recalling certain single-use, disposable Tumor Resection Kits (Model 9733607 Non-Invasive). The recall involves 26,674 units that were distributed nationwide. The specific lot numbers affected are 120416C, 121030D, 130605B, 121010F, 130923C, 131009A, and 130923C.
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 facilities and consumers who have these specific Tumor Resection Kits should stop using them and contact Medtronic Navigation for further instructions on how to return or dispose of the products.
The recalled product
- Product
- TUMOR RESECTION KIT 9733607 NON-INVASIVE
- 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.: 120416C 121030D 130605B 121010F 130923C 131009A 130923C
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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