The FDA today issued a field safety notice deeming a recall of Abiomed Impella 5.5 heart pumps as Class I, the most serious kind. Abiomed — bought by Johnson & Johnson for $16.6 billion last year — recalled 466 affected devices. It distributed these Impella 5.5 with SmartAssist devices between Sept. 28, 2021, and March […]
Recalls
ICU Medical recalls certain infusion pump replacement batteries
The FDA issued a notice determining that the recall of ICU Medical (Nasdaq:ICUI) infusion pump batteries is Class I, the most serious kind. ICU Medical initiated a recall of replacement batteries for certain infusion systems on March 22, 2023. The recall affects its Plum 360, Plum A+ and Plum A+3 infusion systems. The infusion systems […]
Philips: Study shows recalled CPAPs unlikely to cause appreciable harm
Philips (NYSE:PHG) today shared results from a test and research program for the ongoing recall within its Respironics subsidiary. The Amsterdam-based medtech giant says third-party test results determined that issues around its respiratory devices are unlikely to cause appreciable harm to health. These now-completed risk assessments fall in line with results shared by Philips in late […]
Medtronic Diabetes unit fully resolves FDA warning letter
Medtronic (NYSE:MDT) announced today that the FDA lifted the warning letter related to its Diabetes business unit headquarters. In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters. The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of […]
Philips stock rises on Q1 results, recall litigation provision news
Philips reported first-quarter sales growth, plus a litigation update around its ongoing Respironics recall. Shares of PHG ticked up 14% at $21.70 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose 0.1%. Sales for the Dutch medtech giant increased by 6% year […]
Avanos Medical has a serious recall of airway access device for young children
The FDA today issued a notice labeling a recall by Avanos Medical (NYSE:AVNS) as Class I, the most serious kind. Avanos’ recall regards its Ballard Access closed suction system for neonates and pediatrics. These affected devices feature the Y-manifold or elbow manifold. Avanos reported four injuries and one death related to the issue with the […]
Fresenius Kabi recall of Ivenix infusion systems in Class I
The FDA this week said the Fresenius Kabi recall of some Ivenix infusion systems is Class I, the most serious kind. Fresenius Kabi is recalling some Ivenix infusion systems due to a leak in the system that allows fluid to enter the administration set loading area near the air detector. The leak could damage the […]
FDA questions Philips’ replacement respiratory device numbers
The FDA said today that it is clarifying claims by Philips that it has shipped 2.46 million replacement respiratory devices and repair kits in the U.S. The agency claims the number of replacement and remediated CPAPs and other respiratory devices shipped to U.S. consumers is considerably less than the 2.46 million number of “new replacement […]
Philips Respironics recalls some reworked DreamStation devices, deemed Class I by FDA
Issues for Philips (NYSE:PHG) Respironics continue as the FDA deemed a recall of reworked DreamStation devices Class I, the most serious kind. Problems have continued to mount over the past two years or so for the Dutch medtech giant. In 2021, Philips initiated a recall involving millions of CPAP and BiPAP ventilators and other respiratory devices […]
Abbott FreeStyle Libre reader warning affects more than 4 million devices
The FDA today issued a notice classifying a recall of Abbott (NYSE:ABT) FreeStyle Libre readers as Class I, the most serious kind. Earlier this week, Abbott initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. The company said it received a limited number of global reports (0.0017%) from users […]
Abbott warns on some FreeStyle Libre readers due to battery issues
Abbott initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. The instructions cover the FreeStyle Libre, Libre 14-day and Libre 2 readers in the U.S. Abbott received a limited number of global reports (0.0017%) from users over several years saying their reader’s lithium-ion battery swelled or infrequently […]
