Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] issued an urgent field safety notice in Europe to notify customers of updates to its PolarX cryoablation catheters. Marlborough, Massachusetts-based Boston Scientific's notice relates to the PolarX and PolarX FIT cryoablation catheters. These systems work as part of the PolarX … [Read more...] about Boston Scientific warns on some PolarX cryoablation catheters following reports of death
Recalls
Medtronic recalls McGrath Mac laryngoscope due to potential for explosions
The FDA issued a notice deeming a recall of Medtronic [WtwhTicker symbol="MDT"](NYSE: MDT)[/WtwhTicker] 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 … [Read more...] about Medtronic recalls McGrath Mac laryngoscope due to potential for explosions
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 … [Read more...] about Medtronic endotracheal tubes recall sparks an FDA warning
Smiths Medical warns on some Bivona tracheostomy tubes, death reported
ICU Medical's Smiths Medical issued an urgent field safety notice to warn of a potential defect with some of its Bivona tracheostomy products. Posted out of Germany, the warning applies to a number of Bivona neonatal/pediatric and adult tracheostomy tubes. That includes the Aire-Cuf, TTS, Uncuffed and Mid-Range Bivona tubes for … [Read more...] about Smiths Medical warns on some Bivona tracheostomy tubes, death reported
Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
The FDA says a recall of Teleflex (NYSE:TFX) intra-aortic balloon (IAB) catheter kits is Class I, the most serious kind of recall. Teleflex recalled its Arrow FiberOptix IAB catheter kit and Arrow UltraFlex IAB catheter kit. This recall is a correction, not a product removal. However, the issues related to the kits resulted in reports of 31 … [Read more...] about Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
Fresenius Medical Care recalls more than 2 million catheter components
The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind. Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions on Jan. 23, 2024. It extends to nearly 2.2 million devices distributed between March 5, 2003, and … [Read more...] about Fresenius Medical Care recalls more than 2 million catheter components
Boston Scientific has a serious recall involving embolization tech
The FDA announced today that it has designated a Boston Scientific recall of its Obsidio conformable embolic as Class I, its most serious level of recall. The Obsidio embolic is a premixed embolic agent that is delivered in a minimally invasive way through a catheter-based system. The embolic can block or occlude blood flow to specific blood … [Read more...] about Boston Scientific has a serious recall involving embolization tech
Smiths Medical issues urgent field safety notice for some Portex tracheotomy tubes
ICU Medical’s Smiths Medical this week issued an urgent field safety notice for some of its Portex Blue Line siliconized PVC tracheotomy tubes. The company issued the warning due to an issue related to the neck plate or flange of the Portex Blue Line siliconized PVC tracheotomy tubes. The failure mode can happen during use as a complete or … [Read more...] about Smiths Medical issues urgent field safety notice for some Portex tracheotomy tubes
FDA says recall of Cerenovus catheter guide sheaths is serious
The FDA deemed a recall of catheter guide sheaths from Johnson & Johnson’s (NYSE:JNJ) Cerenovus Class I, the most serious kind. Medos International Sàrl, a J&J unit, recalled the Cerenovus Cerebase DA guide sheath and single-use neurovascular guide catheter on Feb. 2, 2024. The company distributed the devices — 1,343 in total — between … [Read more...] about FDA says recall of Cerenovus catheter guide sheaths is serious
Medtronic has a serious catheter tubing recall
The FDA today designated a Medtronic recall of Duet external drainage and monitoring system catheter tubing as Class I, its most serious level. Medtronic Neurosurgery initiated the recall on Jan. 22. According to the FDA, it involves 45,176 devices distributed from May 3, 2021, to Jan. 9, 2024. The model numbers involved are 46913, 46914, 46915, … [Read more...] about Medtronic has a serious catheter tubing recall
