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 […]
Recalls
Philips stock sinks on Q4 China performance, finalizes $1.1B Respironics settlement
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 […]
J&J’s Abiomed updates Impella RP instructions in Class I recall
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 […]
BD warns on atherectomy catheters after deaths
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 […]
Medline has a Class I arterial catheter recall
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 […]
Philips has a serious cardiac monitoring software recall
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 […]
Boston Scientific updates instructions for cryoablation catheters after reported deaths
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 […]
BD to pay SEC $175M to settle Alaris investigation
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 […]
Boston Scientific warns on potential need to replace Accolade pacemaker devices early
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 […]
Philips updates use instructions for several ventilators following recalls
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 […]
FDA says do not use Hologic’s BioZorb marker implants following recall
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 […]
