Medical Device Recall
FDA designates recall of LVAD communication system as class I
Abbott announced it is recalling its left ventricular assist device communication system due to risk for unexpected pump stop or start.
Top news of February: Philips Respironics recall, BMI impact on cardiovascular risk in OSA
Healio has compiled the most-read news in pulmonology posted in February.
FDA: More than 500 deaths reportedly connected to recalled Philips Respironics devices
As of Sept. 30, 2023, there have been 561 reported deaths reportedly connected to recalled Philips Respironics devices, according to an update from the FDA.
Philips Respironics devices no longer being sold in US
Philips Respironics will stop selling its sleep therapy and respiratory care devices in the U.S. until it meets the demands of a consent decree from the FDA, according to a press release from the company.
FDA designates recall of heart-lung machine emergency drive as class I
Getinge announced it is recalling its heart-lung machine emergency drive due to an issue that could prevent the ability of the emergency drive to be cranked.
FDA issues two sets of ventilator recalls
This week, the FDA issued two class I recalls, the most serious kind, for ventilators from two companies.
FDA ‘remains unsatisfied’ in Philips Respironics ventilator, sleep apnea device recall
The FDA asked for more testing regarding the recall of certain Philips Respironics ventilators, bilevel positive airway pressure machines and continuous positive airway pressure machines, according to an update from the agency.
Hamilton Medical recalls more than 20,000 ventilators due to software issues
The FDA has designated Hamilton Medical Inc.’s recall of its HAMILTON-C1, C2, C3 and T1 Ventilators as a class I recall, the most serious kind.
FDA designates Draeger Medical Carina Sub-Acute Care Ventilator recall as class I
The FDA has designated Draeger Medical’s recall of its Carina Sub-Acute Care Ventilator for pediatric patients as a class I recall, the most serious kind.
Abiomed recalls instructions for use for right heart pump due to risk for blood clots
Abiomed announced a recall of the labeling for its right heart pump system catheter because its instructions for use do not appropriately address precautions for patients with anticoagulation clotting time below recommended value.