Maquet Critical Care AB has recalled its FLOW-I Anesthesia system following 10 reports of a patient cassette locking device not working properly. The company initiated the Class I recall April 2 for 1,641 units. If the locking device on the system fails to function properly, it can release the patient cassette from the mount, allowing anesthesia gas to leak. No injuries or deaths have been reported. The system may be used on patients ranging from neonatal to adult.
Medtronic Recalls Tracheostomy Tubes
Medtronic is recalling certain lots of its Covidien Shiley neonatal and pediatric tracheostomy tubes manufactured after Nov. 29, 2012, because they were formed with a wider angle bend than standard models. The Irish devicemaker began alerting customers May 8 after receiving reports of 12 serious patient injuries, including discomfort when using the device and breathing difficulties that affected oxygen levels immediately upon tube placement. The company advises replacing the tubes with products manufactured before Nov. 29, 2012.
Amaze Trial Secures FDA Approval
The U.S. FDA has signed off on SentreHeart’s Amaze clinical trial evaluating the Lariat suture delivery device for closure of the left atrial appendage, as an adjunct to ablation in patients with persistent or longstanding persistent atrial fibrillation. The goal is to demonstrate that use of the device with with pulmonary vein isolation ablation reduces recurrent atrial fibrillation at a higher rate than PVI ablation alone, the Redwood City, Calif., devicemaker says. The Lariat device has both FDA 510(k) clearance and CE Mark certification for other indications.
Sleep Apnea Device Gains 510(k) Clearance
The FDA has cleared SomnoMed’s oral SomnoDent device for mild to moderate obstructive sleep apnea, the Australian devicemaker says. The product provides continuous open airway therapy by positioning the jaw slightly forward. A micro-recording feature developed by Braebon that allows medical professionals to track patient compliance is included in the device.
Optetrak Logic Prosthesis Wins FDA Nod
Exactech’s Optetrak Logic constrained condylar prosthesis for revision knee arthroplasties has snagged FDA 510(k) marketing clearance, the Gainesville, Fla., devicemaker says. The prosthesis is indicated for patients undergoing total knee replacement surgery caused by osteoarthritis, osteonecrosis, rheumatoid arthritis and post-traumatic degenerative problems.
Integra to Buy TEI Biosciences
Integra LifeSciences has entered into an agreement to acquire TEI Biosciences and TEI Medical in for $312 million. The TEI buyout expands Integra’s portfolio of reconstructive surgery and regenerative wound care products, and gives the Plainsboro, N.J., devicemaker access to TEI’s flagship PriMatrix dermal repair scaffold. The deal is expected to close in the third quarter of this year. Waltham, Mass.-based TEI generated revenues of about $63.5 million in 2014.