Cook Medical has launched a voluntary recall of nearly 59,000 devices intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. The Flexor Check-Flo introducer and Flexor Tuohy-Borst side-arm introducer (Shuttle Select) are sterile, single-use devices that incorporate a hydrophilic-coated shaft in varying stiffnesses with distal radiopaque markers. The recall covers […]
Recalls
Boston Scientific’s Lotus layoffs extend to Ireland
Boston Scientific (NYSE:BSX) has reportedly confirmed job losses at its Galway, Ireland, location, following the retirement of the Lotus Edge. Galway Bay FM reported today that the Marlborough, Mass.-based company confirmed the job losses at its Ireland location, adding that Boston Scientific confirmed the job loss will affect fewer than 30 employees. The report said that […]
B. Braun halts certain Aesculap knee implants
B. Braun is notifying customers who purchased certain Aesculap knee systems to temporarily cease implanting them while the company addresses a “possible malfunction.” In a Nov. 16 letter sent to customers worldwide, the company said a “locally accumulated number of aseptic loosenings have been reported to us in connection with the univation X system. ln […]
Alaris remediation could cost BD up to $244M
Becton Dickinson (NYSE:BDX) in its most recent fiscal year set aside $244 million to cover future product remediation costs, including the company’s work to fix its problematic Alaris infusion pumps. The Franklin Lakes, N.J.–based company has had shipments of the pumps on hold since early this year, when FDA called for a comprehensive 510(k) submission to […]
Boston Scientific throws in the towel on Lotus TAVR
Boston Scientific (NYSE:BSX) announced today that it has initiated a global, voluntary recall of its Lotus Edge aortic valve system — and is immediately retiring the Lotus program. Marlborough, Mass.-based Boston Scientific said in a news release that the recall of all unused inventory of its Lotus Edge transcatheter aortic valve repair (TAVR) system is due […]
Feds flag BD’s Alaris pumps for cybersecurity issues
Becton Dickinson (NYSE:BDX) last week issued a notice to warn on potential vulnerabilities with its Alaris infusion pumps. The notification applies to BD’s Alaris PC unit, model 8015, versions 9.33.1 and earlier, as well as the Alaris systems manager, versions 4.33 and earlier, according to a news release. BD was made aware of a network session […]
Medtronic has a Class I recall involving balloon catheters to treat heart defects
FDA today designated a Medtronic recall of Rashkind balloon septostomy catheters as Class I, its most serious level. The balloon catheters create an atrial septal defect or to enlarge an existing atrial septal defect in order to treat congenital heart defects. Medtronic (NYSE:MDT) initiated a recall of the Rashkind balloon septostomy catheters in late August after […]
Baxter has a serious infusion pump recall
Baxter (NYSE:BAX) has issued an urgent device correction involving hundreds of thousands of Sigma Spectrum infusion pumps in which it warns that improper cleaning could cause corrosion around the batteries. So far, Baxter has received 16 reports of serious injuries related to the problem. FDA has labeled the recall as Class I, its most serious level. […]
Medtronic updates instructions for potential risks with CoreValve R, CoreValve Pro TAVR devices
Medtronic (NYSE:MDT) issued a field safety notice to provide updates on rare potential risks with some of its TAVR devices. The CoreValve Evolut R and CoreValve Evolut Pro devices were listed in the notice as devices for which there were updates to the instructions for use manuals, specifically regarding the risk of transcatheter aortic valve (TAV) […]
FDA labels another BD Alaris recall Class I
The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris pump module is Class I, the most serious kind. BD Alaris pump module model 8100 and the Alaris pump module door assembly replacement kits (part numbers 49000346, 49000239, 49000438 and 49000439) were included in the Aug. 4 recall. Those models and parts were […]
Boston Scientific warns on Hurricane RX biliary balloon dilatation catheter
Boston Scientific (NYSE:BSX) said it is initiating the removal of specific lots/batches of its Hurricane RX biliary balloon dilation catheters. Marlborough, Mass.-based Boston Scientific, which issued a voluntary recall from its international location in France, said the removal comes in response to an increase in complaints of the RX tunnel component (black sheath) detaching from the […]
