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The Medical Device Business Journal — Medical Device News & Articles | MassDevice

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Recalls

FDA says Boston Scientific Accolade pacemaker recall is serious

February 21, 2025 By Sean Whooley

The FDA today issued a notice labeling the recall of Boston Scientific Accolade pacemaker devices serious as it may cause injury or death. Last December, Boston Scientific issued a voluntary notice outlining issues with a subpopulation of Accolade, Proponent, Essentio and Altrua 2 dual-chamber standard life and dual-chamber extended life pacemakers and Visionist and Valitude cardiac […]

Filed Under: Cardiac Implants, Cardiovascular, Featured, Food & Drug Administration (FDA), Implants, Recalls, Regulatory/Compliance, Structural Heart Tagged With: Boston Scientific, FDA

Philips stock sinks on Q4 China performance, finalizes $1.1B Respironics settlement

February 19, 2025 By Sean Whooley

Philips shares took a hit today on fourth-quarter results that included potentially concerning performance in China. Shares of PHG fell nearly 12% to $24.92 apiece by midday trading on the NYSE today. The Amsterdam-based medtech giant company reported losses of approximately $347.3 million. That equals 38¢ per share on sales of about $5.3 billion for […]

Filed Under: Business/Financial News, Featured, Health Technology, Legal News, MassDevice Earnings Roundup, Product Liability, Recalls, Regulatory/Compliance, Respiratory, Wall Street Beat Tagged With: Personnel Moves, Philips, Royal Philips

J&J’s Abiomed updates Impella RP instructions in Class I recall

February 14, 2025 By Sean Whooley

The FDA today issued a notice informing customers of updated instructions for the Johnson & Johnson MedTech Abiomed Impella RP heart pump. Impella RP offers up to 14 days of use in patients who develop acute right heart failure after left ventricular assist device (LVAD) implantation. Placed in the internal jugular vein, it supports the […]

Filed Under: Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Structural Heart Tagged With: Abiomed, FDA, Johnson & Johnson, Johnson & Johnson MedTech

BD warns on atherectomy catheters after deaths

February 10, 2025 By Sean Whooley

BD recently issued a medical device correction later related to its Bard subsidiary’s Rotarex atherectomy system. The company identified a number of anatomical factors that could contribute to catheter helix fracture and/or breakage. It reports 30 serious injuries and four deaths associated with the issue. Additionally, BD reported 115 cases requiring additional intervention following helix […]

Filed Under: Catheters, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Stents, Vascular Tagged With: Bard, BD, FDA

Medline has a Class I arterial catheter recall

February 7, 2025 By Sean Whooley

The FDA labeled a recall of integrated arterial catheters made by Medline Class I, the most serious kind of recall. This recall involves removing certain devices from where they are used or sold. The company reports no injuries or deaths related to this recall to date, according to an FDA notice. Medline designed its arterial […]

Filed Under: Blood Management, Catheters, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Vascular Tagged With: FDA, MedLine

Philips has a serious cardiac monitoring software recall

January 13, 2025 By Chris Newmarker

The FDA announced today that a Philips recall involving remote cardiac monitoring software is Class I, its most serious recall designation. On Dec. 18, 2024, Philips and its subsidiary Braemar Manufacturing sent health provider customers an Urgent Medical Device Correction, notifying them that, in some cases, the monitoring service application for its MCOT (BTPS-1000) devices […]

Filed Under: Cardiovascular, Diagnostics, Digital Health, Featured, Health Technology, Recalls, Regulatory/Compliance, Software / IT Tagged With: Philips

Boston Scientific updates instructions for cryoablation catheters after reported deaths

December 19, 2024 By Sean Whooley

The FDA issued a notice alerting customers to updates made by Boston Scientific to its PolarX cryoablation catheters. This recall involves updating instructions for use (IFU), not removing devices from the market. The FDA identified it as the most serious type of recall, though, as it may cause serious injury or death. Boston Scientific updated […]

Filed Under: Cardiovascular, Catheters, Food & Drug Administration (FDA), Pulsed-Field Ablation (PFA), Recalls, Regulatory/Compliance Tagged With: Boston Scientific, FDA

BD to pay SEC $175M to settle Alaris investigation

December 17, 2024 By Sean Whooley

BD announced that it reached an agreement with the SEC to resolve an investigation related to its Alaris system. The investigation relates to prior public disclosures and SEC reporting regarding Alaris, an infusion pump system. BD neither admits nor denies the findings of an SEC order related to those matters occurring more than four years […]

Filed Under: Business/Financial News, Drug Pumps, Drug-Device Combinations, Featured, Health Technology, Legal News, Recalls, Regulatory/Compliance Tagged With: Alaris, BD

Boston Scientific warns on potential need to replace Accolade pacemaker devices early

December 16, 2024 By Sean Whooley

The FDA today issued an alert after Boston Scientific warned of the potential need for the early replacement of certain pacemaker devices. This month, Boston Scientific issued a notice to customers saying that it identified issues with a subpopulation of Accolade, Proponent, Essentio and Altrua 2 dual-chamber standard life and dual-chamber extended life pacemakers and […]

Filed Under: Cardiac Implants, Cardiovascular, Featured, Food & Drug Administration (FDA), Implants, Recalls, Regulatory/Compliance, Structural Heart Tagged With: Boston Scientific, FDA

Philips updates use instructions for several ventilators following recalls

November 20, 2024 By Sean Whooley

The FDA issued a notice updating instructions for a number of ventilators made by Philips (NYSE:PHG) Respironics. This recall involves updating instructions for devices, not removing them from use or sale. The FDA identified the recall as the most serious kind, as it may cause serious injury or death. It relates to an October warning […]

Filed Under: Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Respiratory Tagged With: FDA, Philips, Philips Respironics

FDA says do not use Hologic’s BioZorb marker implants following recall

October 29, 2024 By Danielle Kirsh

The FDA is advising consumers and healthcare providers not to use BioZorb Markers and BioZorb LP Markers made by Hologic following a recent recall. Hologic issued a voluntary recall on October 24 for all unused BioZorb markers following reports of serious adverse events in patients who had the devices implanted in breast tissue. The company […]

Filed Under: Food & Drug Administration (FDA), Recalls, Regulatory/Compliance, Women's Health Tagged With: Hologic

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