Medtronic Issues Class I Recall for 45,176 Duet External Drainage and Monitoring System Catheters Due to Disconnection Risk

Mar 08, 2024 17:56 CST Updated 17:57

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On March 7, the FDA announced MedtronicThe recall of the Duet External Drainage and Monitoring System Catheter has been classified as a Class I recall.

Screenshot from the FDA official website

According to reports,The reason for the recall is that the catheter may disconnect from the patient's line stopcock connector.If catheter disconnection occurs, potential harm to the patient may include infection, cerebrospinal fluid (CSF) leakage, excessive CSF drainage, and ventricular abnormalities; if undetected, excessive CSF drainage can lead to neurological damage or death.

According to the FDA announcement,The number of products recalled by Medtronic in the United States this time is 45,176., involving the distribution time of the recalled productsMay 3, 2021 to January 9, 2021, Product Model:46913, 46914, 46915, 46916, and 46917Catheter. It is reported that Medtronic, plc. voluntarily initiated the recall on January 22, 2024.Currently, 26 people are injured, and no deaths have been reported.

Medtronic Class I Recall

It is reported that the Duet External Drainage and Monitoring System (EDMS) canPatients undergoing open thoracic descending aortic aneurysm or open thoracoabdominal aortic aneurysm surgeryProvides temporary cerebrospinal fluid drainage or cerebrospinal fluid sampling, and is also suitable for individuals who have undergone related surgeries and are experiencing symptoms such as paraplegia.

The Duet External Drainage and Monitoring System includes a green-striped tube, stopcock, drip chamber, pressure gauge, needle-free injection/CSF sampling port, as well as a movable measurement bag and a vent.The system uses gravity to allow cerebrospinal fluid to flow from the external lumbar catheter through the patient's catheter into the drip chamber, and finally into the collection bag.It is generally recommended to use it in conjunction with the separately provided Clear-Site Laser Level.

On January 23, 2024, Medtronic sent an Urgent Medical Device Recall to all affected customers.The letter requests that all unused and unexpired products in inventory be returned to Medtronic according to the instructions included in the customer confirmation form.

It is reported that the reason for this recall is that the catheter may disconnect from the patient line stopcock connector.If catheter disconnection occurs, potential harm to the patient may include infection, cerebrospinal fluid leakage, excessive cerebrospinal fluid drainage, and ventricular abnormalities; if undetected, excessive cerebrospinal fluid drainage may lead to neurological damage or death.

It is understood that the Duet external drainage and monitoring system catheter involved in Medtronic's recall this timeSpecific model numbers include 46913, 46914, 46915, 46916, and 46917.

Medtronic stated in the letter that customers need to check whether all components are damaged, and whether all connections are secure and free of leaks.If the patient is currently connected to the affected Duet EDMS and a leak or disconnection is detected, the device should be replaced with a new alternative device using sterile technique.; At the same time, it is not recommended to remove or replace the Duet system device connected to the patient and found to be working as expected after inspection.

Achieved Revenue of $8.1 Billion in Q3 2024

Strong business growth momentum

Medtronic is a global leading medical technology company dedicated to providing lifelong treatment solutions for patients with chronic diseases, with a product range coveringCardiovascular diseases, neurological disorders, diabetes, renal diseases, and other fields,Products include various medical devices, equipment, and related healthcare products, such as pacemakers, stents, insulin pumps, etc.

As a medical technology company, Medtronic is also committed to researching and developing new medical technologies. The company has numerous research and development centers and production bases worldwide, with a total workforce of over 90,000 employees.Its business is mainly divided into four major segments: the Cardiovascular Business Group, the Medical Surgical Business Group, the Neuroscience Business Group, and the Diabetes Business Group., covering more than 150 countries and regions worldwide.

Recently, Medtronic announced its third-quarter financial report for the fiscal year 2024, which ended on January 26.The report shows that the company's quarterly revenue was $8.1 billion (approximately 58.2 billion RMB), a year-on-year increase of 4.7%.Quarterly net profit was US$1.34 billion, increasing by 8.8% year-on-year.

Screenshot source: Medtronic official website

Medtronic's organic revenue growth reflects the company's overall continued momentum,Mainly benefiting from the strong growth in diabetes, core spine, cardiac surgery, structural heart, and cardiac rhythm management businesses, as well as its strength in international markets.

From the perspective of specific business units, all four of Medtronic's businesses achieved positive growth.The growth in the diabetes business was the most significant (12.3%, $640 million).; followed by cardiovascular (6.1%, $2.93 billion); neuroscience (4.3%, $2.36 billion); and medical surgical (3.9%, $2.15 billion).

Screenshot source: Medtronic official website

Medtronic Chairman and CEO Geoff Martha said, "As we once again firmly fulfill our commitments this quarter, our momentum is building.We continue to achieve sustainable revenue growth, performing well across multiple business areas and international markets as we expand the reach of innovative medical technologies globally."Our recent major product approvals – including transformative products in the fields of diabetes, cardiac rhythm management, neuromodulation, hypertension, and pulsed field ablation – have strengthened our confidence in driving consistent growth over the next few quarters and years."

Announcement of Exiting the Ventilator Business

It is worth mentioning that, at the same time as announcing its financial report, MedtronicAlso announced the withdrawal from the ventilator production line, and the remaining Patient Monitoring and Respiratory Interventions (PMRI) business will be merged and reorganized into the Acute Care and Monitoring (ACM) division.

This major resolution announced that after more than a year, the mystery surrounding the final destination of Medtronic's PMRI business has finally been unveiled.Medtronic announced in October 2022 that it would spin off its PMRI division.According to Reuters, GE Healthcare, Siemens Healthineers Clayton, ICU Medical, and others were interested in acquiring its divested business.

In the end, private equity giant Carlyle Group took the lead and entered into negotiations with Medtronic. According to media reports, the proposed acquisition price exceeded $70 billion (approximately RMB 51.1 billion).

This time, Medtronic chose to halt its ventilator business, directly overturning the previous strategy of spinning off the PMRI division.The company chose to exit the ventilator business because, as the pandemic stabilized, ventilators have become increasingly unprofitable.But in the eyes of the company, the remaining business of the PMRI division still holds investment value.

Medtronic CEO Geoff Martha said that the ventilator business has seen increasing losses over the past year.Its PMRI (Patient Monitoring & Respiratory Interventions) division reported revenue of $532 million in the third quarter, a year-over-year increase of 1.9%, ranking second to last among all separately listed business segments in the earnings report. The funds saved from closing the ventilator business will boost investment in the new division (ACM).Especially in the field of remote patient monitoring.

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At the JP Morgan Healthcare Conference in early 2024, Medtronic Chairman and Chief Executive Officer Geoff Martha stated,As part of its restructuring efforts to improve company profitability, Medtronic plans to close more than five manufacturing sites and six distribution centers, and cease business with nearly 200 suppliers.

In fact,Previously, Medtronic stated that the company had begun to "significantly cut costs" in response to macroeconomic issues.In March 2023, Medtronic launched a voluntary early retirement incentive program; in April of the same year, Medtronic began global layoffs.

It can be seen that, as the global economy cools, even Medtronic, the industry leader, is struggling to resist this "cold spell." However,Medtronic Remains Confident in Future Development.

On the occasion of announcing the latest financial report,Medtronic also raised its revenue growth and earnings per share (EPS) forecast for the fiscal year 2024, increasing the organic revenue growth prediction from the previous 4.75% to a new range of 4.75% to 5%.This indicates its optimism and confidence in the medical device market.

So, in the face of a complex industry environment,How will Medtronic respond to this recall incident next? Will this recall affect its market confidence for 2024?Instrument之家 will continue to follow up.

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