Massachusetts-based medical device maker Covidien (NYSE:COV) announced a voluntary recall of certain Power Pac batteries distributed with its Newport HT70 and HT70 Plus ventilators, according to an FDA notice.
Respiratory
ResMed takes aim at APEX Medical over respiratory device patents
Recall: Spacelabs Healthcare pulls anesthesia workstations over excess CO2 risk
Washington-based Spacelabs Healthcare recalled a slate of its Spacelabs BleaseSirius and BleaseFocus anesthesia workstations as well as certain absorbers contained in service kits over concerns that they may contain a defect which could result in excess carbon dioxide in the gas delivered to a patient.
Hamilton Medical recalls ventilation systems over software issue
Swiss ventilation devices maker Hamilton Medical recalled certain of its Hamilton-T1 ventilators over concerns that a software glitch may harm pediatric patients.
The FDA gave the recall Class I status, a category reserved for device malfunctions "in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
ResMed slides despite record Q2 sales and profits
ResMed (NYSE:RMD) shares fell nearly 7% this morning after the medical device company posted record sales and profits for its fiscal 2nd quarter, but missed Wall Street’s earnings expectations.
The San Diego-based medical device company posted profits of $77.9 million, or 53¢ per share, on sales of $376.5 million for the 3 months ended Dec. 31, 2012.
Recall: Ventlab pulls more than 14k defective manual respirators
Respiratory devices company Ventlab Corp. announced a nationwide recall of thousands of its manual resuscitators over concerns that the devices may not delivery enough or any air or oxygen to patients
The recall, which the company initially launched in July, affects more than 14,600 units across 12 different products, including the company’s RescueMed Infant Resuscitator and Premium Small Child Resuscitator, according to a press release.
EarlySense lands FDA clearance for its updated monitoring systems
Massachusetts-based medical device maker EarlySense received FDA clearance for its oximetry-integrated bedside system and central display system to help the clinicians provide a higher level of supervision for post-surgical patients.
FDA labels Accutron recall Class I over nitrous oxide leak that may harm patients
The FDA slapped Accutron’s recall of 206 flowmeters with Class I status, the agency’s designation for the most serious type of recall.
The agency warned that the flowmeters, which the company recalled earlier this month over leaking nitrous oxide, could lead to temporary or permanent brain damage or death.
GPO: Novation awards airway management contract to Intersurgical
National group purchasing organization Novation awarded a new agreement to Intersurgical for its i-gel supraglottic airway management device, the company announced today.
The i-gel system uses a gel-like thermoplastic cuff to seal the pharynx and esophageal opening in adults and pediatric patients, a change from traditional devices that use air to create a seal using inflation.
Teleflex lands FDA nod for its disposable endobronchial blocker
Global medical device company Teleflex (NYSE:TFX) received FDA clearance for its Rusch EZ-Blocker disposable endobronchial blocker.
The device is designed to imitate the bifurcation of the trachea in order to enable safer lung isolation and single-lung ventilation to help doctors reduce the risk of dislocation during surgery.
FDA clears Respiratory Motion’s new monitoring system
Massachusetts-based medical device maker Respiratory Motion won FDA approval for its ExSpiron respiratory monitoring system, the 1st monitor to provide continuous, noninvasive minute ventilation data to improve safely in non-ventilated patients.
Minute ventilation data, the amounts of air that enter and leave the lungs every minute, have not been previously available to doctors "across the continuum of care," according to the company.