The FDA determined that the recall of certain Eitan Medical Sapphire infusion pumps is Class I, the most serious kind. Netanya, Israel-based Eitan recalled certain Sapphire pumps running software version Rev 16.10. The recall includes the Sapphire multi-therapy pump, the Sapphire Epidural pump and the Sapphire Plus pump. Eitan initiated the recall on Sept. 11, […]
Recalls
FDA warns of thermal issues with Philips DreamStation 2 CPAP machines
The FDA is warning patients and health care providers to watch Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The medical device safety agency said it recently received an influx of medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while […]
B. Braun infusion pump battery recall is Class I after one reported death
The FDA labeled a recall of B. Braun Medical infusion pump battery packs Class I, the most serious kind. B. Braun’s recall is a correction, not a product removal, affecting the battery pack for its Infusomat Space large-volume pump. It affects both wireless and non-wireless batteries, model numbers 8713051U and 8713052U. According to an FDA […]
Asensus has a Class I Senhance surgical robot recall
The FDA deemed a recall of the Asensus Surgical (NYSE:ASXC) Senhance surgical robot as Class I, the most serious kind. Asensus recalled its Senhance system due to malfunctions causing unintended movement of the robotically-assisted surgical device. The issue presented itself as an uncontrolled arm motion of the laparoscope instrument actuator (LI). In this case, the […]
Baxter recalls some syringe pumps due to underdosing risk
The FDA determined that the recall of the Baxter Novum IQ syringe pump is Class 1, the most serious kind. Baxter designed its Novum IQ syringe pump as an infusion pump to deliver fluids into a patient’s body in a controlled manner. The device is suitable for patient care in hospitals and outpatient facilities for […]
FDA issues warning about over-the-counter eye drops
The FDA issued a notice warning consumers about 26 over-the-counter eye drop products that could result in eye infections. In its notice, the FDA instructed consumers not to purchase and to immediately stop using these products. Using those eye drops could lead to the risk of infections that could result in partial vision loss or […]
Olympus warns on insufflation unit after reported death, other complications
Olympus announced a field corrective action in the U.S. due to over-insufflation during use of its UHI-4 high-flow insufflation unit. The company designed UHI-4 to facilitate laparoscopic and endoscopic observation, diagnosis and treatment. It insufflates the abdominal cavity and colon, providing automatic suction and smoke evacuation. Olympus received complaints of patients suffering complications from over-insufflation […]
Philips CEO Roy Jakobs reportedly approved continued sale of defective sleep respiratory devices
A new report from ProPublica and the Pittsburgh Post-Gazette claims to shed more light on the alleged role of Philips CEO Roy Jakobs in the ongoing Respironics recall. Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. […]
Fresenius Medical Care has a Class I recall of some hemodialysis machines
The FDA issued a notice declaring a recall of some Fresenius Medical Care hemodialysis machines as Class I, the most serious kind. Fresenius Medical Care recalled some of its 2008 Series hemodialysis machines that may cause exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) that leach from some peroxide-cured silicone tubing used as part of […]
Philips stock rises on Q3 growth, increased 2023 outlook
Philips (NYSE:PHG) shares ticked up today on third-quarter results that came in ahead of the consensus forecast on Wall Street. Shares of PHG rose 2.8% at $18.77 apiece in late-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.14%. The Amsterdam-based company posted profits […]
FDA issues warning letter to J&J’s Abiomed over Impella heart pump problems
Abiomed, a Johnson & Johnson unit, has received an FDA warning letter related to its Class I recall of Impella heart pumps. The agency wrote Abiomed up for failing to report problems with the heart pump and selling its Impella Connect System software and hardware without FDA authorization. The FDA issued the letter in September after inspecting […]