Boston Scientific issued an urgent field safety notice to warn of a software anomaly that may occur with its Avvigo+ multi-modality guidance system. Avvigo+, a next-generation system, provides intravascular ultrasound (IVUS) and fractional flow reserve (FFR). It uses advanced software and hardware to provide high-quality IVUS vessel imaging and physiology experience. The system’s uses include […]
Recalls
Medtronic recalls McGrath Mac laryngoscope due to potential for explosions
The FDA issued a notice deeming a recall of Medtronic McGrath Mac video laryngoscopes Class I, the most serious kind. This recall involves removing certain devices from where they are used or sold as the device may cause serious injury or death if people continue using it. It also includes updating instructions for using other […]
Inari Medical updates ClotTriever XL catheter instructions for use following reports of injury and death
Inari Medical has updated its instructions for using some ClotTriever XL catheters in a Class I recall due to injury and death reports. The company recalled and updated use instructions after discovering serious adverse events caused by the device entering or blocking the lung arteries. The use of affected products could continue to cause serious […]
Recall of Medtronic nerve monitoring tech is Class I
The FDA identified a recall of Medtronic nerve monitoring systems as Class I, the most serious kind of recall. This recall involves correcting devices, not removing them from the market. The device may cause serious injury or death if people continue using it without correction, the FDA says. Medtronic’s correction involves its NIM vital nerve […]
Boston Scientific warns some Wavewriter Alpha SCS systems may stop and reset while charging
Boston Scientific is warning that some WaveWriter Alpha spinal cord stimulation implantable pulse generator (IPG) devices could suspend therapy. The company said stimulation therapy could be “transiently suspended” while charging due to a device reset. The reset occurs in response to potential interference during IPG charging. When the system resets, the patient’s programmed stimulation turns […]
Abbott recalls some FreeStyle Libre 3 sensors in U.S.
Abbott — a major company in the continuous glucose monitor (CGM) market — has a recall to report. According to our sibling site Drug Delivery Business News, Abbott announced today that it initiated a voluntary recall for a small number of FreeStyle Libre 3 continuous glucose monitor (CGM) sensors. The company distributed the affected sensors […]
Baxter’s Class I ventilator recall includes product removals
Baxter is removing certain ventilator devices from where they are used or sold following an FDA Class I recall. The company first sent customers an urgent medical device recall letter related to its Life2000 ventilator on May 29. On June 26, the FDA listed the recall as Class I, the most serious kind, as device […]
FDA corrects death tally in Philips ventilator recall
The FDA issued a clarification that significantly trims the number of deaths reportedly associated with a recall of Philips Respironics ventilators. On June 28, the FDA issued a Class I recall notice involving potential Ventilator Inoperative alarm failures on BiPAP V30, BiPAP A30, BiPAP A40 devices. At the time, the FDA cited 952 reports of […]
Medtronic endotracheal tubes recall sparks an FDA warning
The FDA issued a notice instructing healthcare providers to stop using certain reinforced endotracheal tubes made by Medtronic (NYSE:MDT). This warning extends to NIM Contact EMG reinforced endotracheal tubes and NIM (Standard) EMG reinforced endotracheal tubes. Medtronic offers the neural integrity monitor (NIM) electromyogram (EMG) tubes for surgical procedures. They provide an airway for patient […]
Inspire Medical has a serious implantable pulse generator recall
The FDA labeled a recall of Inspire Medical Systems (NYSE:INSP) implantable pulse generators (IPGs) Class I, the most serious kind. Inspire initiated a recall of its IV IPG on June 17. The recall involves removing certain devices from where they are used or sold. It extends to 32 devices of the Model 3028 IPG. To […]
Philips’ MR coils recall is Class I
The FDA has labeled Philips’ recall of some Sense XL Torso Coils as Class I, the most serious kind. Royal Philips (NYSE:PHG) has recalled all serial numbers of specific Sense XL Torso (1.5T and 3.0T) coils due to a potential issue with the coil heating up during MRI scans, which could lead to thermal injury. The […]
