Medtronic Issues New Class I Recall for Becker and Exacta External Drainage Systems Amid Leakage Risks

Feb 05, 2025 17:39 CST Updated 17:40

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Recently,FDA Issues Class I Recall of Medtronic Device,Request Medtronic to recallBecker and Exacta DevicesAccording to reports, the recall this time isMedtronic's system for draining cerebrospinal fluid has risks of rupture and leakage.

Currently, there have been 15 injury reports, with no deaths.The FDA stated that the affected devices could lead to cerebrospinal fluid leakage, infection, or even death.

It is reported that Medtronic will keep these devices on the market but has requested suppliers to inspect the stopcocks and connectors for visible cracks. Suppliers who find cracks or leaks should return the devices to Medtronic.

It is worth mentioning that, previously, FThe FDA and China's National Medical Products Administration (NMPA) issued a Class I recall for Becker and Exacta EDM in November and December 2024, respectively, with over 210,000 units recalled in the Chinese market.

Medtronic Level One Recall

It is understood that Medtronic's Becker and Exacta devices provide a complete closed system for draining cerebrospinal fluid from the brain. These devices also enable healthcare professionals to monitor fluid pressure and flow rate. The stopcocks and connectors facilitate fluid movement.

The FDA recall notice describes the risk of rupture and leakage in the device stopcock. Medtronic sent a letter to customers in November after receiving complaints about the stopcock.Depending on the system configuration, the stopcock may be located in three different parts of the drainage system.

The FDA said there have been no reports of patient deaths due to cracks or leaks, but because of the potential risk of serious injury and death, the agency classified this recall as the most serious type.Medtronic stated in its November letter to customers that it had reported three adverse events related to patient infections.

Medtronic has advised suppliers to monitor all patients for signs of infection as recommended on the product label. If cracks or leaks are found in the system during use, monitoring of the patient should continue. The company stated that faulty devices should be replaced using sterile techniques.

FDA and Medtronic have also provided recommendations on how to prevent leaks. Medtronic stated that suppliers should check all equipment fittings to ensure they are tightened and leak-free, but only finger-tightened connections are required. Over-tightening the connections may cause cracks and leaks.

The product was recalled 210,000 units in China.

Data shows,The Exacta External Drainage and Monitoring System can be used for ventricular or lumbar drainage and features a reusable rod clamp scale, which helps reduce waste disposal and inventory levels.The system can be mounted on a standard IV pole to help keep the patient's bedside clean.

In terms of scope of application, the system is used for drainage and monitoring of cerebrospinal fluid (CSF) flow in the lateral ventricle or lumbar subarachnoid space in selected patients: 1. To reduce intracranial pressure (ICP), such as preoperatively, intraoperatively, or postoperatively. 2. To monitor the chemical, cellular, and physiological properties of CSF. 3. To provide temporary external CSF drainage in patients with infected CSF shunts.

It is worth mentioning that, on December 31,China's National Medical Products Administration (NMPA) website released a voluntary recall notice for a medical device product.Information shows that over-tightening of the three-way valve may cause cracks or leaks. If the pre-use inspection is not carried out according to the instructions, it could potentially lead to infection. Therefore,Medtronic Inc. voluntarily recalls its Exacta external drainage and monitoring system (China Medical Device Registration No. 20163145109, China Medical Device Registration No. 20163665109).

According to the specific system configuration of the recalled products,The three-way valve may be located in three different positions within the system. Over-tightening the three-way valve can cause cracks or leaks, compromising the integrity of the drainage system.If the pre-use inspection is not carried out according to the instructions, it may constitute a risk.

Medtronic's Recent Developments in Intensive Care

Notably, the recalled products belong to Medtronic's Critical Care portfolio.In the past few years, Medtronic's critical care business has undergone various adjustments, including production line restructuring and personnel changes.

In June 2023, Medtronic announced that it would increase investment in five key areas: neurovascular, structural heart, soft tissue robotics, diabetes, and AFib (atrial fibrillation).At the same time, it will divest its kidney care/dialysis business, patient monitoring, and respiratory interventions business to streamline its portfolio.

However, in view of the short-term surge in sales of one of the business branches of patient monitoring services—the Nellcor™ pulse oximeter—Medtronic eventually abandoned its decision to spin off the patient monitoring business. It only divested the ventilator business and announced in February 2024 that it would merge the two operating divisions of Patient Monitoring and Respiratory Interventions into a new operating division named Acute Care and Monitoring (ACM).

Among them, Medtronic's ACM business includes monitoring technology, oximetry technology, respiratory intervention platforms, etc.

And in August 2024,Six months after reversing the divestiture of its patient monitoring business, Dr. Sam Ajizian, Chief Medical Officer of Medtronic Acute Care and Monitoring (ACM), announced his departure on LinkedIn.Ajizian has worked in the department for nearly 4 years.

Recent Important Developments of Medtronic

It needs to be emphasized that, despite undergoing industry challenges in the intensive care sector—such as a series of product recalls, production line reorganizations, and personnel changes—Medtronic has recently made significant progress in multiple areas, drawing considerable attention from the industry.

Finance and Stock

In terms of financial and stock performance,The second quarter report of 2025 shows that Medtronic's revenue reached 8.403 billion US dollars, increasing by 5.25% year-on-year; the net profit was 1.269 billion US dollars, increasing significantly by 39.60% year-on-year, showing a good profit trend.

In the stock market, on February 4, Medtronic's closing price in Vienna was 87.26 euros, representing a 0.83% decrease from the previous trading day. Meanwhile, in the U.S. stock market,The trading volume reached 472 million US dollars, closing at 90.97 US dollars, up by 0.49% from the previous day.Over a longer period, the stock price fell by 1.10% in the past five trading days.Up 0.17% in February, with a year-to-date increase of 13.88%, and up 4.86% over the past 52 weeks.

Personnel Changes

In terms of personnel changes,Medtronic inOn January 21, an important appointment was announced: Thierry Piéton will serve as the company's new Chief Financial Officer (CFO), with the appointment taking effect on March 3, 2025.It is reported that Piéton previously worked for the Renault Group, under his leadership, Renault achieved its highest-ever operating profit margin and improved free cash flow. He has extensive experience in the healthcare and other highly regulated, operation-focused manufacturing fields, having worked for Nissan Motor Co., General Electric Company, GE Healthcare, and PricewaterhouseCoopers.

This appointment,Thierry Piéton Will replace Karen Parkhill, who left Medtronic in June 2024 to join HP after serving as the company's Chief Financial Officer for eight years. Over the past seven months,Gary CoronaActing as the interim Chief Financial Officer until Piéton arrives.Gary CoronaWill transition to the role of Senior Vice President of Finance and continue to serve as a member of the company's Executive Committee.

Product Development and Advancement

In product development and project advancement,Medtronic's Next-Generation Renal Denervation (RDN) Catheter and Procedure Development Project "Gemini" Achieves New Progress.This project aims to upgrade the Symplicity Spyral system and procedure, which were approved by the U.S. Food and Drug Administration (FDA) in 2023 for the treatment of hypertension. According to reports, the Gemini project combines renal denervation with hepatic artery denervation. Preclinical studies have shown that performing these two procedures simultaneously can have a greater impact on blood pressure.

Medtronic has fully developed the next-generation catheter that can be accessed through the wrist, which is expected to enter the market in about 18 months, while the current generation of catheters is accessed through the femoral artery.In addition, Medtronic is conducting in-depth research on the current system and procedures through the global Symplicity registry study and Affirm trial to evaluate the long-term outcomes, safety, and focus on the conditions of different patient subgroups.

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As the industry leader,MedtronicHave been highly anticipated.Medtronic's 2024 financial report shows overall revenue growth, with total revenue reaching $32.4 billion, a year-on-year increase of 3.6%; however, net profit declined, with net profit at $3.676 billion, a year-on-year decrease of 2.2%.But overall, Medtronic had a good start in the fiscal year 2025 and also raised its full-year performance guidance.

It should be noted that, against the backdrop of an industry-wide downturn, the previously high growth in the patient monitoring sector is returning to rational levels. Major manufacturers have no choice but to adapt to the new trends by adjusting their production lines. Therefore, will the impact of Medtronic's recent recall of Becker and Exacta devices be reflected in its financial reports? Medical Device News will continue to monitor the situation.

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