Medtronic Recalls Patient Tracker Devices Due to Sterility Control Issues
Medtronic Navigation is recalling single-use Patient Tracker devices because returned units 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 medical device where sterility cannot be assured due to a lack of control over returned units. This represents a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Navigation, Inc. is recalling certain single-use, disposable Patient Tracker devices (model 9733534XOM ENT 1PK). The recall involves 26,674 units that were 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 control raises concerns about the ability to ensure the sterility of the devices.
The affected devices are identified by specific lot numbers, including 131212C, 130827E, 131113B, and others listed in the official recall notice. Consumers and healthcare providers should stop using these devices and contact Medtronic Navigation for further instructions.
The recalled product
- Product
- PATIENT TRACKER 9733534XOM ENT 1PK
- 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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