Medtronic Recalls Non-Invasive Shunt Kits Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 non-invasive shunt kits because returned devices were not adequately inspected for damage that could compromise sterility.
What this means for you
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 is classified as FDA Class II. The hazard involves a risk of harm (compromised sterility) for a medical device, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the SHUNT KIT 9733605 NON-INVASIVE. These are single-use, disposable medical devices distributed nationwide. The recall involves specific lot numbers including 120628B, 130204E, and 131127A.
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 compromise 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 affected units.
The recalled product
- Product
- SHUNT KIT 9733605 NON-INVASIVE
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — Surgical Kits
- 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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