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On October 17, the official website of the National Medical Products Administration showed that Covidien Healthcare International Trading (Shanghai) Co., Ltd. reported,Due to the unauthorized sale of some endoscopic laryngoscopes, which should have been destroyed, by a third-party destruction company on overseas social media platforms in Mexico, these products may cause harm to patients.Plexus Electronica S.de R.L.de C.V., the manufacturer, voluntarily recalled the McGRATH MAC Video Laryngoscope (Registration No. 20222080633) it produced.Recall level is Level 1 recall.

For detailed information regarding the model, specifications, and batch of the product, please refer to the "Medical Device Recall Event Report Form".

So, why did the laryngoscopes that should have been destroyed end up leaking out? A search by Medical Device News on foreign websites revealed,On September 27, Medtronic issued a warning stating that the defective products were distributed through theft., and illegally sold on social media platforms.

And inform the public how to identify the defective products in this batch.

McGRATH MAC Video Laryngoscope, indicating the location of the serial number and two types of genuine packaging. Image source: Medtronic

May cause death

The McGRATH MAC Video Laryngoscope is a medical device used to assist with tracheal intubation. Studies have shown that, compared to direct laryngoscopy, the use of the McGRATH MAC Video Laryngoscope can improve the first-attempt success rate of tracheal intubation in patients undergoing elective surgery.

Medtronic stated,The McGRATH MAC video laryngoscope stolen this time failed to pass the quality inspection and was scheduled to be destroyed.This defect may lead to harm from failed laryngoscopy and/or intubation. Surgical failure can result in respiratory failure, hypoxia, associated cardiac issues, high carbon dioxide levels in the blood, tissue damage, etc.

Medtronic did not explain why the products were stolen and statedThe stolen products this time did not have Medtronic's typical label packaging.Products included in its recall serial number form (see Medtronic's official website for details) and McGRATH MAC video laryngoscopes without serial numbers should all be considered recalled and defective products.

Only products with serial numbers not included in this recall, and having the two types of packaging boxes announced by Medtronic, are genuine and up to standard.

Currently, some laryngoscopes have appeared on various social media platforms through unauthorized third-party sellers.Medtronic stated that the company is cooperating with regulatory and law enforcement authorities to remove unauthorized advertisements and recover stolen defective products.

China Cracks Down on 20 Million Yuan Case

Medical devices, due to their high value, are not uncommon targets for theft and smuggling. These devices often end up in second-hand markets in less developed countries or are sold for veterinary use.

Boston Scientific

In April 2011, a batch of medical devices from Boston Scientific was stolen while being transported for sterilization.The stolen products include endoscopes, urology, and women's health medical devices. Although the products are labeled as "sterile," they have not actually been disinfected, which may lead to infections and complications.

Johnson & Johnson

In September 2016, a former sales representative of Ethicon Endosurgery, a Johnson & Johnson company, was convicted of conspiracy to transport stolen medical devices in interstate commerce, money laundering, and other charges. The employee was found guilty of seven felonies.More Than 20 Convictions for Medical Device Theft, Involving Total Fines and Compensation Exceeding $5 Million

China Breaks Two Million Yuan Major Case

In 2021, a major medical device smuggling case involving 20 million yuan was cracked in China. According to the investigation by the Fuzhou Customs Anti-Smuggling Bureau, the smuggling gang's hideout was located in a residential area in Putian City.Although it is called a network office, inside is a medical device company in Hangzhou, Zhejiang.

Since 2018, the gang has smuggled large quantities of second-hand gastroscopes and colonoscopes from Japan, refurbished them, and sold them to hundreds of private hospitals across 15 provinces in China for profit.After a preliminary investigation, the smuggling gang is suspected of smuggling 418 used gastrointestinal endoscopes, with an estimated case value of more than 20 million yuan.

In addition to this recall caused by the company's theft, Medtronic and its subsidiary Covidien Healthcare have been involved in multiple recalls this year. The following lists only a few of the larger-scale incidents.

350,000 Devices, Level 1 Recall

On July 19, several models of implantable defibrillators under Medtronic were classified as Class I recall by the FDA.

The recall covers all ICDs and CRT-Ds with glass feedthroughs manufactured after 2017. The affected products include the Cobalt XT, Cobalt, and Crome ICD and CRT-D, as well as the Claria MRI, Amplia MRI, Compia MRI, Viva, and Brava CRT-D.The quantity is as high as 348,616 units, marking the largest recall of this series of products by Medtronic since its launch.

The reason for the recall is that the device's energy output is unstable, which may lead to cardiac arrest.Currently, the series of devices has caused 22 people to be injured.

China Issues Level 1 Recall of 28,000 Medical Devices

On May 30, Medtronic (Shanghai) Management Co., Ltd. reported that during high-voltage therapy, when the programming setting is AX>B, there is an increased likelihood of reduced or no energy delivery in specific batches of implantable device products. As a result, the manufacturer, Medtronic Inc., initiated a voluntary recall of implantable cardioverter defibrillators and other implantable devices (registration certificate numbers are detailed in the attachment). The recall is classified as a Level 1 recall.

On the same day, Covidien Healthcare International Trading (Shanghai) Co., Ltd. reported that due to manufacturing deviations in specific batches of connector components, their diameter is smaller than the standard value. This potential issue may lead to insecure connections between the device connectors and protective caps or other accessories. The manufacturer, Covidien LLC, initiated a voluntary recall of tracheostomy tubes (China Medical Device Registration No. 20172085250, 20172085027). The recall level is Class I.

Four Recalls Issued in China in a Single Day

According to the news released on the official website of the National Medical Products Administration on September 15, Medtronic initiated four recalls on the same day.

1. Medtronic (Shanghai) Management Co., Ltd. reported that due to the incorrect expiration date printed on the finished product labels of specific batches of specific models of floor pads, the manufacturer, Medtronic Inc.Medtronic Initiates Voluntary Recall of Electrode Delivery Sheath (Registration No. 20173142128). Recall Level: Class II.

2. Medtronic (Shanghai) Management Co., Ltd. reported that due to incompatibility between the updated A710 CP application (v2.0.136) and the existing A901 Communication Manager application (v1.0.1169), the A710 CP application is unable to communicate with the Implantable Neurostimulator (INS)/Wireless External Neurostimulator (WENS). Manufacturer: Medtronic Inc.Voluntary recall of the doctor-programming system for spinal cord neurostimulators (China Medical Device Registration No. 20202120339), the patient programmer (China Medical Device Registration No. 20232120219), and the programming device for neuromodulation equipment (China Medical Device Registration No. 20192120588). The recall level is Class II recall.

3. Medtronic (Shanghai) Management Co., Ltd. reported that due to some electronic Instructions for Use (eIFU) not yet being published online, the manufacturer, Medtronic Inc.Voluntary recall of implantable deep brain stimulation extension leads (China Medical Device Registration No. 20173126055), implantable spinal cord nerve stimulation electrodes (China Medical Device Registration No. 20203120516), implantable spinal cord nerve stimulation extension lead kits (China Medical Device Registration No. 20163125128), and implantable spinal cord nerve stimulation electrode kits (China Medical Device Registration No. 20203120515). The recall level is Class III recall.

4. Medtronic (Shanghai) Management Co., Ltd. reported that the clinical programmer tablet has been registered on the development server instead of the production server and is intended for product demonstration or training purposes by Medtronic personnel only.Medtronic Inc. voluntarily recalls neurostimulation programming devices (Registration No. 20192120588, imported medical device in China). The recall is classified as a Level III recall.

——

On August 22, 2023, Medtronic announced its Q1 financial report for the fiscal year 2024, which ended on July 28, 2023, and raised its full-year forecast.

Total revenue for the first quarter of fiscal year 2024 was $7.7 billion, representing a reported growth of 4.5% and an organic growth of 6.0%, surpassing market expectations.; According to the report, the GAAP net income for the first quarter was $791 million (approximately 5.76 billion RMB), a decrease of 15%; non-GAAP net income was $1.596 billion (approximately 11.63 billion RMB), an increase of 6%.

Medtronic Raises Organic Revenue Growth Guidance for FY2024 from 4.0%-4.5% to 4.5%, and Increases Non-GAAP Diluted Earnings Per Share Guidance from $5.00-$5.10 to $5.08-$5.16, Above Market Consensus of $5.05.

So, will the impact of multiple recalls show up in Medtronic's financial reports in the future? Medical Device News will continue to monitor.

END

 

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