The manufacturer Medtronic has published the following safety information due to stolen and subsequently illegally marketed non-compliant medical devices of the type "McGRATH MAC Video Laryngoscope".
October 2023 – Medtronic is issuing this notification to inform the public of stolen defective McGRATH™ MAC video laryngoscopes that have been offered for sale illegally by unauthorized third parties through various social media platforms. These affected products did not pass Medtronic’s rigorous quality tests established for the product, were not released for sale, distribution, or importation, and were designated for destruction. These affected products are defective and should not be used. Medtronic is working closely with regulatory authorities, and law enforcement organizations to help ensure that unauthorized advertisements are being removed as identified, and actions to recover the stolen defective products are underway. The McGRATH™ MAC video laryngoscope is a device used to facilitate intubation of the trachea. The use of a defective McGRATH™ MAC video laryngoscope may result in patient harm, 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 procedure/extended hospitalization).
Patient safety remains at the core of the Medtronic Mission to alleviate pain, restore health, and extend life. Medtronic urges healthcare professionals to purchase products only from trusted and reliable sources, such as directly from Medtronic or its authorized distributors. To find an authorized distributor or to purchase directly from Medtronic, contact Customer Service at (+1) 800-962-9888, Option 2. Medtronic will continue to work closely with regulatory authorities and law enforcement agencies toward resolution of this issue. Anyone with information regarding the promotion or sale of potentially stolen products are encouraged to contact Medtronic Customer Service at (+1) 800- 962-9888, Monday through Friday from 8AM to 7PM ET
|McGRATH™ MAC Video-Laryngoskope
|Medtronic Österreich GmbH
|Die betroffenen Seriennummern sind in der beigefügten PDF Datei gelistet.
UPDATE: 09.11.: zusätzlich identifizierte Seriennummern finden Sie im beiliegenden PDF Dokument.
|Das BASG empfiehlt grundsätzlich dringend, Medizinprodukte ausschließlich über vertrauenswürdige Vertriebskanäle zu beziehen.