The recall was put in place after a customer discovered “visible black particulate matter” in a sealed vial. If the contaminant enters a patient's blood vessels, it could lead to serious complications, including a stroke or even death. The recall was put in place after a customer discovered “visible black particulate matter” in a sealed vial. If the contaminant enters a patient's blood vessels, it could lead to serious complications, including a stroke or even death. | | |
|
A Florida family is suing Mayo Clinic for allegedly performing a heart transplant without communicating certain risks associated with the donated organ. Mayo Clinic has pushed back against those claims, saying it acted appropriately every step of the way. A Florida family is suing Mayo Clinic for allegedly performing a heart transplant without communicating certain risks associated with the donated organ. Mayo Clinic has pushed back against those claims, saying it acted appropriately every step of the way. | | |
|
The agency warned that any unused devices should be removed from the market and returned to the manufacturer. The agency warned that any unused devices should be removed from the market and returned to the manufacturer. | | |
|
The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained. The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained. | | |
|
The new warnings, first proposed to Pfizer and Moderna in April, are now officially required by the FDA. They provide additional information about the potential risks of myocarditis and/or pericarditis associated with these vaccines. The new warnings, first proposed to Pfizer and Moderna in April, are now officially required by the FDA. They provide additional information about the potential risks of myocarditis and/or pericarditis associated with these vaccines. | | |
|
U.S. News & World Report has released its annual ranking of the top U.S. hospitals for cardiology, heart surgery and vascular surgery. Did your facility make the cut this year? U.S. News & World Report has released its annual ranking of the top U.S. hospitals for cardiology, heart surgery and vascular surgery. Did your facility make the cut this year? | | |
|
Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. Philips is recalling the software associated with its Mobile Cardiac Outpatient Telemetry devices after certain high-risk ECG events were never routed to trained cardiology technicians as intended. The issue, which lasted for two years, has been linked to more than 100 injuries. | | |
|
The 55-year-old patient woke up experiencing chest pain one morning and an ambulance was called. He was dead just a few hours later. His family's lawsuit argued that delays in care, communication errors and other issues were directly responsible for his death. The 55-year-old patient woke up experiencing chest pain one morning and an ambulance was called. He was dead just a few hours later. His family's lawsuit argued that delays in care, communication errors and other issues were directly responsible for his death. | | |
|
More than 100 incidents have been reported so far. The FDA is still evaluating this issue, but the agency wanted to raise awareness as quickly as possible. More than 100 incidents have been reported so far. The FDA is still evaluating this issue, but the agency wanted to raise awareness as quickly as possible. | | |
|
After years of trying to catch up with the competition, Boston Scientific is moving on. The company is no longer seeking approval from the FDA or any other regulatory agencies for these devices, and all global sales have been discontinued. After years of trying to catch up with the competition, Boston Scientific is moving on. The company is no longer seeking approval from the FDA or any other regulatory agencies for these devices, and all global sales have been discontinued. | | |
|
