Defective Medtronic products
Defective products - Medtronic McGRATH™ MAC video laryngoscopes
In October 2023, Medtronic published a notification concerning McGRATH™ MAC video laryngoscopes, which are used to facilitate intubation of the trachea.
A large number of products that failed Medtronic's quality tests and were designated for destruction were stolen and have been offered for sale illegally by unauthorised third parties through various social media platforms.
Using these defective products may be harmful to patients – including failed laryngoscopy and/or intubation – potentially resulting in respiratory failure (including hypercarbia), hypoxia (leading to bradycardia, dysrhythmias), hypercapnia, tissue damage/tissue trauma and/or a delay to treatment (prolonged procedures/extended hospitalisation).
Affected McGRATH™ MAC video laryngoscopes
- Devices without a serial number
- Devices with the item code '301-000-000' and marked with the serial numbers listed in Document FA1370 - Serial numbers of defective devices (Pdf, 109 Kb)
Action to take
The defective products should not be used.
If you possess any of these devices, or if you see them on the market, please immediately contact the medical device market surveillance authority, i.e. the Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments) of the Health Directorate, at meddevices@ms.etat.lu.
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