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Inari Medical (NARI) Issues Notice Post ClotTriever XL Recall
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Inari Medical, Inc. (NARI - Free Report) has announced critical updates to the instructions for using its ClotTriever XL Catheter, 30mm, a device designed to remove clots from large blood vessels. This action follows a recall issued by the FDA, which was identified as the most serious type due to reported adverse events, including serious injuries and deaths. The recall focuses on updating usage guidelines to prevent life-threatening complications, such as device entrapment, vessel damage and a pulmonary emboli, but does not remove the product from the market.
Inari Medical launched the ClotTriever XL Catheter in April 2023. NARI has updated the instructions for its ClotTriever XL Catheter, adding critical warnings and procedural guidelines to enhance patient safety. These updates include specific instructions to avoid pulling the catheter through certain veins to prevent advancing clots into the heart or pulmonary arteries and consider the potential risk of pulmonary thromboembolism when removing clots from large vessels like the inferior vena cava. Additionally, the guidelines now recommend using a clot entrapment device to minimize the risk of embolization and advise against attempting to remove large clots in a single pass.
Inari Medical has issued a voluntary field notice for the ClotTriever XL catheter, providing updated procedural guidance for physicians. This update, which is not related to any device defect, aims to enhance the use of ClotTriever XL for treating complex deep vein thrombosis (DVT) and is expected to have no impact on revenues.
Significance of Recall
This recall by Inari Medical is of high significance as it aims to address severe safety risks associated with the ClotTriever XL Catheter. The updated instructions are crucial for preventing serious health consequences, including potential death, particularly in patients with fibrous, adherent, or calcified clots, as well as those with suspected tumor thrombus and caution against the use of clot capture devices in the venous system. With four reported injuries and six deaths linked to improper usage, the FDA’s recommendations highlight the necessity for healthcare providers to strictly follow the revised guidelines. NARI is also ensuring that all relevant training materials are updated and healthcare providers are adequately informed to mitigate these risks.
More on the News
In response to the recall, Inari Medical sent an Urgent Medical Device Labeling Correction to all affected customers on Jul 19, 2024. The letter advises healthcare providers to review the new instructions, share them with relevant personnel and complete an acknowledgment form. NARI is also updating all related training materials to ensure that healthcare providers are fully informed of the risks and proper usage techniques, especially when dealing with complex clot scenarios.
Industry Prospects
Per a report in Precedence Research, the global thrombectomy devices market size was worth $1.52 billion in 2023. It is anticipated to reach $3.09 billion by 2033, witnessing a CAGR of 7.33%.
The robust growth is mainly driven by its critical role in restoring blood flow in veins and arteries, which helps prevent life-threatening conditions like stroke, pulmonary embolism and heart attacks. By quickly addressing blood clots, these devices minimize bodily damage and preserve activity levels, making them essential in treating various conditions, including DVT and acute limb ischemia. These benefits are key factors fueling the expansion of the thrombectomy device market.
Price Performance
Shares of Inari Medical have plunged 33.2% so far this year against the industry’s 9.7% growth. The S&P 500 has witnessed an 18.2% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Inari Medical carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Universal Health Services (UHS - Free Report) , Quest Diagnostics (DGX - Free Report) and ABM Industries (ABM - Free Report) . While Universal Health Services sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Universal Health Services has an estimated long-term growth rate of 19%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.
Universal Health Services has gained 41.1% compared with the industry's 34.8% growth so far this year.
Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.31%.
Quest Diagnostics’ shares have gained 3.7% so far this year compared with the industry’s 10.2% growth.
ABM Industries’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.
ABM's shares have risen 24.1% so far this year compared with the industry’s 11.9% growth.
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Inari Medical (NARI) Issues Notice Post ClotTriever XL Recall
Inari Medical, Inc. (NARI - Free Report) has announced critical updates to the instructions for using its ClotTriever XL Catheter, 30mm, a device designed to remove clots from large blood vessels. This action follows a recall issued by the FDA, which was identified as the most serious type due to reported adverse events, including serious injuries and deaths. The recall focuses on updating usage guidelines to prevent life-threatening complications, such as device entrapment, vessel damage and a pulmonary emboli, but does not remove the product from the market.
Inari Medical launched the ClotTriever XL Catheter in April 2023. NARI has updated the instructions for its ClotTriever XL Catheter, adding critical warnings and procedural guidelines to enhance patient safety. These updates include specific instructions to avoid pulling the catheter through certain veins to prevent advancing clots into the heart or pulmonary arteries and consider the potential risk of pulmonary thromboembolism when removing clots from large vessels like the inferior vena cava. Additionally, the guidelines now recommend using a clot entrapment device to minimize the risk of embolization and advise against attempting to remove large clots in a single pass.
Inari Medical has issued a voluntary field notice for the ClotTriever XL catheter, providing updated procedural guidance for physicians. This update, which is not related to any device defect, aims to enhance the use of ClotTriever XL for treating complex deep vein thrombosis (DVT) and is expected to have no impact on revenues.
Significance of Recall
This recall by Inari Medical is of high significance as it aims to address severe safety risks associated with the ClotTriever XL Catheter. The updated instructions are crucial for preventing serious health consequences, including potential death, particularly in patients with fibrous, adherent, or calcified clots, as well as those with suspected tumor thrombus and caution against the use of clot capture devices in the venous system. With four reported injuries and six deaths linked to improper usage, the FDA’s recommendations highlight the necessity for healthcare providers to strictly follow the revised guidelines. NARI is also ensuring that all relevant training materials are updated and healthcare providers are adequately informed to mitigate these risks.
More on the News
In response to the recall, Inari Medical sent an Urgent Medical Device Labeling Correction to all affected customers on Jul 19, 2024. The letter advises healthcare providers to review the new instructions, share them with relevant personnel and complete an acknowledgment form. NARI is also updating all related training materials to ensure that healthcare providers are fully informed of the risks and proper usage techniques, especially when dealing with complex clot scenarios.
Industry Prospects
Per a report in Precedence Research, the global thrombectomy devices market size was worth $1.52 billion in 2023. It is anticipated to reach $3.09 billion by 2033, witnessing a CAGR of 7.33%.
The robust growth is mainly driven by its critical role in restoring blood flow in veins and arteries, which helps prevent life-threatening conditions like stroke, pulmonary embolism and heart attacks. By quickly addressing blood clots, these devices minimize bodily damage and preserve activity levels, making them essential in treating various conditions, including DVT and acute limb ischemia. These benefits are key factors fueling the expansion of the thrombectomy device market.
Price Performance
Shares of Inari Medical have plunged 33.2% so far this year against the industry’s 9.7% growth. The S&P 500 has witnessed an 18.2% rise in the same time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Inari Medical carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Universal Health Services (UHS - Free Report) , Quest Diagnostics (DGX - Free Report) and ABM Industries (ABM - Free Report) . While Universal Health Services sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Universal Health Services has an estimated long-term growth rate of 19%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.
Universal Health Services has gained 41.1% compared with the industry's 34.8% growth so far this year.
Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.31%.
Quest Diagnostics’ shares have gained 3.7% so far this year compared with the industry’s 10.2% growth.
ABM Industries’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.
ABM's shares have risen 24.1% so far this year compared with the industry’s 11.9% growth.