Recently, the U.S. Food and Drug Administration (FDA) issued an announcement thatMedtronic's Recall of Multiple Video Laryngoscopes Designated as Class I Recall.This is the FDA's most serious recall level, meaning that using the device could lead to severe injury or even death.

It is reported that MedtronicMcGrath Mac and McGrath Mac EMS Video LaryngoscopesIt is a commonly used device in medical surgeries, helping doctors view the patient's trachea through a camera.Reasons for the recall include issues such as potential battery depletion or explosion, significantly affecting the normal use of the device.As of now, one user has reported an injury incident, but there have been no reports of death.

According to the FDA announcement,This recall involves the McGrath MAC Video Laryngoscope and McGrath MAC EMS Video Laryngoscope, which are equipped with a light source and a miniature camera.Can provide doctors with a clearer view of the throat during laryngoscopy.

Partial Recall of Older Models

The specific recall models are 15060272980020 (300-000-000) and 15060272980129 (300-200-000), with device serial numbers ranging from 366170 to 405673.These devices will be required to be fully withdrawn from the market. Users must immediately stop using them and return the devices to Medtronic. The batteries also need to be removed and disposed of.

New Model Recalled as Needed

For the new generation of McGrath MAC video laryngoscopes, model numbers 10884521823396 (301-000-000) and 10884521776494 (301-000-000). Medtronic advises users to check the battery storage conditions and ensure safe battery usage according to the instructions for use.If the battery is in good condition and within the safe usage period, the device can continue to be used; if the battery component does not meet storage conditions or has been dropped, it should be handled immediately and replaced with a new component.

Medtronic pointed out that the use of the affected devices may lead to a series of health issues, such as burns, cuts, tissue damage, tooth loss, eye injuries, hearing loss, tinnitus, respiratory failure, hypoxia, and even death.

Nearly 1,000 Units Recalled in China

In fact,Medtronic Issued an Urgent Medical Device Removal and Correction Notice to Customers in July.After handling the battery components, users should return the device to the company. For the next-generation devices with updated instructions, customers may continue to use them provided they follow the relevant guidelines.

Subsequently, on August 13, Medtronic's Covidien HealthcareMedtronic initiates a voluntary recall of the same series of laryngoscopes in China.Nearly a thousand devices were affected.

Notably, this is not the first time that issues have arisen with the McGrath Mac video laryngoscope.

As early as September 2023, Medtronic issued a safety notice to inform the publicA batch of defective McGrath Mac video laryngoscopes was stolen and illegally sold by some unauthorized third parties.Medtronic recalled after discovering these stolen devices.5,709 unitsAffected Devices.

Subsequently, the FDA classified the incident as a Class I recall, noting that these defective devices had appeared for sale on social media platforms, including Facebook Marketplace. Medtronic stated that some of the stolen devices had been recovered, but the specific distribution locations remained unclear. Fortunately, no related complaints or injury reports caused by these devices have been received.

Although the FDA stated that these devices are only available in the United States, it will not be long before...Covidien Medical reported to the National Medical Products Administration in China,Reported that some disposable video laryngoscopes, which were supposed to be destroyed, were sold by a third-party destruction company on overseas social media platforms without approval in Mexico. This has led to potential patient harm. The manufacturer, Plexus Electronica S.de R.L.de C.V., has issued a notice regarding its product, the McGRATH MAC Video Laryngoscope.(China Medical Device Registration No. 20222080633)Voluntary recall.

Instrument Family found after checking,The McGrath Mac series of laryngoscopes, originally a product under Covidien, were first launched in October 2010.In 2015, Medtronic spent $42.9 billion to acquire Covidien.Also included in the acquisition is Covidien'sAll product lines. This was also the most notable acquisition in the history of the medical device industry at the time.

However,Medtronic has initiated multiple recalls since its acquisition of Covidien.

Ventilator Recalled Three Times

2021At the end of the year, due to a manufacturing error, Medtronic initiated a recall of the Puritan Bennett 980 series ventilators.This is reportedly the third Class I recall of the product by Medtronic since its acquisition of Covidien in 2015.

According to the entry in the FDA Recall Database,This recall is due to a "manufacturing assembly error," where the capacitors inside the ventilator were incorrectly assembled, which may cause the device to fail during use.This recall was initiated on November 4, involving 278 units.

In 2015, Medtronic initiated a recall of more than 650 ventilators.Because the amount of air delivered to the patient may be less than the planned amount;In 2018, the software update was recalled to address issues with the user interface.

The 2018 software update was released more than a year after the suspension of device supply in Australia. The Therapeutic Goods Administration, under Australia's Department of Health, suspended the supply of these devices following multiple reports of black screens, unresponsive user interfaces, and unexpected shutdowns or reboots.

"The reason for this action is that the TGA is concerned that the use of these ventilators will increase the potential risk of death, serious injury, or illness unless corrected," the regulatory agency said in a statement in September 2017. The initial suspension was for six months; however, after reviewing the product, another six-month suspension was applied.

TGA finally lifted the suspension in November 2018 and listed the conditions that Medtronic must comply with, including updating the wording of warnings and instructions in the user manual.

Catheter Recall

June 2022,More than 1 million blood dialysis catheters produced by Covidien, a subsidiary of Medtronic, have been identified for a Class I recall.Covering the equipment manufacturingManufactureMultiple models of nine distinct catheters sold under the Palindrome and Mahurkar product names by 商.

January 2023,Medtronic Initiates Voluntary Recall of Mahurkar Acute Dual-Lumen High-Flow (13.5 Fr) Hemodialysis Catheters Manufactured by Covidien, Involving Over 300,000 Units.The reason for the recall is that "gaps" present in the central hubs of some catheters may lead to internal leakage during hemodialysis, which could potentially cause cross-contamination between the two lumens of the catheter.

In June 2023, MedtronicInitiated action againstUrgent Recall of Mahurkar™ Acute and Mahurkar™ Acute High Pressure CathetersInvolve approximately 210,000 catheters worldwide. The recall was due to the discovery that the relevant catheters might become blocked because of the accumulation of silicone-based lubricants.

END

 

More exciting content

Welcome to follow WeChat Video Channel

Instrument Family

Related Reading

Tap for more!

Orthopedic Giant Medtronic Changes Leadership in Greater China

2024 Global Top 100 Medical Device Companies, Mindray Ranks 27th

Johnson & Johnson May Face $7.1 Billion in Damages Due to Surgical Robot

The King of Valves, Medtronic, Begins Global Layoffs

Big Data of Radiotherapy Equipment in the First Half of the Year: United Imaging Healthcare Ranks First Among Chinese Manufacturers

First in the Industry, Mindray Makes the List

Samsung Completes Acquisition of an Imaging Company

Dilemma? Leading Chinese-Made Medical Device Company Sees Dual Decline in Revenue and Profit

Major Announcement: Jingfeng Medical Makes a Big Move

Review of Semi-Annual Reports from Leading Chinese Endoscope Manufacturers: Mindray, Aohua, Kaili……

BusinessBusiness cooperation email: qxzj@landianyiliao.com