On Thursday, the FDA released an announcement regarding Medtronic’s decision to recall two of its devices — the McGrath MAC Video Laryngoscope and the McGrath MAC EMS Video Laryngoscope. Additionally, Medtronic issued updated instructions for the Next-Generation McGrath MAC Video Laryngoscope, which they are not removing from distribution.
Medtronic announced the recall in July, 2024, after one report of injury caused by a battery defect. The company says an explosion of the battery is possible when the battery depletes below a certain threshold and becomes overheated. Such an explosion can cause serious injuries, including damage to tissues in the form of cuts and burns; damage to the face and mouth, including the eyes and teeth; damage to the ears, accompanied by impaired hearing; and in the most serious instances, respiratory failure, leading to oxygen deprivation and possible death.
The company is removing from distribution the McGrath MAC Video Laryngoscope (UDI # 15060272980020/300-000-000) and the McGrath MAC EMS Video Laryngoscope (UDI # 15060272980129/300-200-000). The recall applies to all devices with serial numbers in the range of 366170 and 405673. Customers should be able to find the UDI near the barcode on the packaging for the device or printed on the device itself. The serial number is printed on the device handle under the housing for the battery assembly. Health-care providers and distributors should discard the battery assemblies for these devices and return the devices to Medtronic.
In addition to the recall on these two devices, Medtronic has issued an addendum to the instructions for use for the Next-Generation McGrath MAC Video Laryngoscope (UDI #s 10884521823396/301-000-000 and 10884521776494/301-000-000). Customers can continue to use this device but should review the addendum. Additionally, customers should be sure to replace the battery assembly according to the “use by date,” which is printed on the back of the current McGrath 3.6V assembly. Customers should also be careful to store batteries appropriately according to the updated instructions for use. If batteries have not been stored properly or if they have been dropped, customers should dispose of and replace the impacted assemblies.
Any questions about the recall or the updated instructions for use can be directed to Medtronic at 1-800-962-9888, Option 2. Alternately, customers can speak directly with their assigned Medtronic representative.
If you or a loved one has suffered an adverse health outcome that can be attributed to a defective medical device, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to health care facilities in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.