Philips will pay at least $613 million to settle economic lawsuits related to its recall of millions of CPAPs and other respiratory devices. U.S. District Court Judge Joy Flowers Conti, who has been overseeing the multidistrict litigation out of her court in Western Pennsylvania, approved the final settlement yesterday. “The amount of value created and […]
Recalls
Boston Scientific warns on some Vercise Genus implantable pulse generators
Boston Scientific recently issued an urgent field safety notice for certain Vercise Genus deep brain stimulation (DBS) implantable pulse generators. In the urgent field safety notice released in the United Kingdom, the company warned about the potential for Vercise Genus DBS IPG stimulation therapy to be transiently suspended during charging due to a device reset. […]
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 […]
FDA says InfuTronix infusion pump recall includes 1 death
The FDA today shared new information on an infusion pump recall from InfuTronix that included one report of death. Following a voluntary removal, the FDA deemed the recall Class I, the most serious kind, earlier this month. It affects 52,328 devices in the U.S. in total. Today, the agency shared that a slew of issues […]
FDA labels Outset Medical recall of Tablo hemodialysis system as Class I
The FDA today labeled Outset Medical’s recall of some Tablo hemodialysis devices as Class I, the most serious kind. The news comes only weeks after analysts expressed optimism that the company was moving ahead of previous regulatory challenges with the FDA. Outset Medical recalled certain Tablo hemodialysis systems after non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) leaching […]
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 to block or occlude blood flow to specific blood […]
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 […]
Abbott has another serious LVAD recall
The FDA today labeled Abbott’s recall of some HeartMate II and HeartMate 3 left ventricular assist systems (LVAS) as Class I, the most serious kind. Abbott issued the recall of the HeartMate II and HeartMate 3 LVAS due to an issue known as extrinsic outflow graft obstruction (EOGO). The issue happens when biological material builds […]
ICU Medical’s Smiths Medical has a serious ventilators recall
The FDA recently labeled Smiths Medical’s recall of some ventilators as Class I, the most serious kind. ICU Medical’s Smiths Medical initiated a recall of some ASD PneuPac paraPAC Plus 300 and 310 Ventilator kits on February 7. The company said the ventilators may intermittently provide continuous positive gas flow instead of the intended cycling […]
Philips comes to consent decree agreement with DOJ, FDA over Respironics recall
Philips today announced a final agreement on a consent decree with the FDA and U.S. Dept. of Justice (DOJ). The consent decree primarily focuses on its Philips’ Pennsylvania-based Respironics business — the subject of a major recall over the past several years. That includes manufacturing facilities in Murrysville and New Kensington, a service center in […]
FDA says recall of Cerenovus catheter guide sheaths is serious
The FDA deemed a recall of catheter guide sheaths from Johnson & Johnson’s 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 June 14, […]