The FDA this week said the Medtronic recall of some NIM Contact Reinforced EMG endotracheal tubes is Class I, the most serious kind. Medtronic is recalling its NIM Contact Reinforced EMG endotracheal tubes and NIM Standard Reinforced EMG endotracheal tubes due to reports of obstruction of the endotracheal tube while in use in patients. Tube … [Read more...] about FDA labels Medtronic recall of some endotracheal tubes as Class I
Ra Medical enters agreement to merge with Catheter Precision
Ra Medical Systems today announced it entered a merger agreement with Catheter Precision. Under terms of the agreement, Catheter Precision will become a wholly-owned subsidiary of Ra Medical in a stock-for-stock reverse merger transaction. Upon completion, the combined publicly traded company will focus on the cardiac electrophysiology … [Read more...] about Ra Medical enters agreement to merge with Catheter Precision
Haemonetics wins CE mark for Vascade vascular closure device
Haemonetics today announced it received CE mark approval for its Vascade vascular closure and Vascade MVP venous vascular closure systems. The CE mark approval will allow the Boston-based company to enter specific markets in the European Union, as well as other regions that recognize the regulatory marking. Haemonetics designed the Vascade … [Read more...] about Haemonetics wins CE mark for Vascade vascular closure device
LeMaitre Vascular warns on some Syntel Silicone over-the-wire embolectomy catheters
LeMaitre Vascular (NSDQ:LMAT) recently issued an urgent field safety notice for some of its Syntel Silicone over-the-wire embolectomy catheters. The Burlington, Massachusetts-based company issued the warning due to the French size next to the outside diameter symbol on the label not reflecting the 5 Fr catheter extrusion used on all models of … [Read more...] about LeMaitre Vascular warns on some Syntel Silicone over-the-wire embolectomy catheters
Gore voluntarily recalls some balloon catheters
W.L. Gore and Associates recently announced the voluntary product recall of its Molding and Occlusion Balloon (MOB) Catheters. The Newark, Delaware-based manufacturing company issued the warning due to complaints of leakage from the guidewire lumen and the y-hub during the preparation or use of the MOB catheters. The issue could result in … [Read more...] about Gore voluntarily recalls some balloon catheters
Medtronic warns on Prevail Paclitaxel-coated PTCA balloon catheter
Medtronic this week issues an urgent field safety notice for some of its Prevail Paclitaxel-coated PTCA balloon catheters. The Fridley, Minnesota-based company issued the warning due to the potential for an incorrect compliance chart attached to the catheter hoop. The balloon size on the compliance chart differed from the balloon size detailed … [Read more...] about Medtronic warns on Prevail Paclitaxel-coated PTCA balloon catheter
Kurin launches full-scale manufacturing of push-button needle system
Kurin today announced it has begun full-scale production on its automated machines for the Advance Safety Needle System. San Diego-based Kurin designed the push-button needle as part of its blood culture collection set to reduce the risk of blood culture contamination. “We are pleased with the transition to automated manufacturing of the … [Read more...] about Kurin launches full-scale manufacturing of push-button needle system
Medtronic launches Onyx Frontier drug-eluting stent
Medtronic (NYSE:MDT) today launched its newest drug-eluting coronary stent, Onyx Frontier. The Fridley, Minnesota-based company designed the Onyx Frontier drug-eluting stent (DES) to build upon its Resolute Onyx DES. It uses the same stent platform as the Resolute Onyx and has an enhanced delivery system to increase acute performance in … [Read more...] about Medtronic launches Onyx Frontier drug-eluting stent
Imagin Medical acquires Trod Medical’s enCage Coil precision ablation system
Imagin Medical this week announced it has acquired Trod Medical's enCage Coil precision ablation system. The company will acquire the enCage Coil for $2.5 million, which will be paid over time once certain developmental milestones are met. There will be an initial payment on the closing of $350,000 and $150,000 of Imagin shares. Of the initial … [Read more...] about Imagin Medical acquires Trod Medical’s enCage Coil precision ablation system
Endo Tools Therapeutics announces first commercial cases of Endomina endoscopic suture device
Endo Tools Therapeutics (ETT) this week announced the first U.S. commercial cases using its Endomina system. Gosselies, Belgium-based ETT designed Endomina for endoscopic placement of sutures and approximation of soft tissue in the gastrointestinal tract. The first procedures were performed at Brigham and Women's Hospital in Boston, … [Read more...] about Endo Tools Therapeutics announces first commercial cases of Endomina endoscopic suture device
