FDA today designated a Philips recall of certain sleep and respiratory devices as Class I, its most serious level. Devices in the recall number in the millions, according to FDA’s database. There have been more than 1,200 complaints and more than 100 injuries involving polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. The foam has […]
Recalls
FDA raises concerns about NuVasive Magec devices
The FDA today issued a notice warning patients, caregivers and healthcare providers of potential issues with Magec devices from NuVasive (NSDQ:NUVA). NuVasive’s Magec, a growing spinal rod system intended for use in children under 10, uses magnets to help correct spinal deformities as the child grows. The company designed Magec to help avoid multiple operations while […]
FDA warns of biocompatibility concerns with NuVasive’s Precise devices
The FDA today informed healthcare providers of potential biocompatibility concerns with Precice devices from NuVasive (NSDQ:NUVA). Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a […]
Medtronic has a Class I recall of some angiographic guidewires
The FDA has classified the recall of some angiographic guidewires made by Medtronic (NYSE:MDT) as Class I, the most serious kind. Medtronic’s angiographic guidewire component affected by the recall helps place catheters into the vasculature during angiography or other interventional procedures. The recall occurred because of a lack of sterilization before shipment to hospitals, according […]
Teva initiates U.S. recall of Topotecan metastatic ovarian cancer injection treatment
Teva Pharmaceuticals (NYSE:TEVA) initiated a voluntary recall of a lot of its Topotecan injection 4mg/4mL (1mg/mL) in the U.S. The voluntary recall came as a result of a complaint received from a pharmacy after a single glass particle was observed inside one vial. Following further examination of the complaint sample, two other particulates were found and […]
Medtronic warns on Linq II insertable cardiac monitoring systems
Medtronic (NYSE:MDT) recently issued a warning letter regarding an issue with its Linq II insertable cardiac monitors (ICMs). Fridley, Minn.-based Medtronic’s warning informs users that Linq II ICMs that undergo a partial electrical reset appear to be programmed “ON,” but are no longer able to detect and report Brady, Pause and PVC events to clinicians. […]
Philips CPAP recall could be an opportunity for ResMed, analysts say
Baird analysts say that the recall of certain sleep and respiratory devices by Royal Philips (NYSE:PHG) may benefit ResMed (NYSE:RMD). Earlier this month, Amsterdam-based Philips provided an update on the April 26 recall for some bi-level PAP and CPAP ventilator devices with a foam component problem, with the company expecting revenue headwinds in its sleep […]
Smiths Medical recalls some insulin syringes over skewed graduation marking
Smiths Medical announced today that it issued recall notices for its Jelco Hypodermic Needle-Pro fixed needle insulin syringes. Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward […]
Philips issues recall involving sleep and respiratory care devices
Royal Philips (NYSE:PHG) today provided an update on the recall for some bi-level PAP and CPAP ventilator devices with a foam component problem. On April 26, Philips issued a recall notification for specific Philips bi-level positive airway pressure (bi-level PAP), continuous positive airway pressure (CPAP) and mechanical ventilator devices due to potential risks related to […]
J&J must reportedly throw out 60M COVID-19 vaccine doses from Emergent plant
Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out. The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination. Get the full […]
Medtronic stops sales of its HVAD system
Medtronic (NYSE:MDT) announced today that it has stopped distributing and selling its HeartWare Ventricular Assist Device (HVAD) system. Fridley, Minn.-baed Medtronic this morning issued a notice to physicians informing them to stop new implants of the HVAD system and to transition to an alternative means of durable mechanical circulatory support, according to a news release. […]
