Farmacovigilanza

UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

Renuvion/J-Plasma device with new handpiece can be used for certain aesthetic skin procedures.

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Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm

The iCast catheter-placed stent supports the walls of structure within the body. The balloon or catheter hub may separate during removal, causing harm to the patient.

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Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers

Illumina cybersecurity vulnerability affecting software could impact patient health results.

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Baxter Issues Urgent Medical Device Correction to Reinforce Important Safety Information Regarding Possible Risk of Oxygen Desaturation While Using Volara Device in Line With Ventilator in a Home Care Environment

Deerfield, Ill. – 2022-06-01 - Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Volara System (home care) to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may resul

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Ukoniq (umbralisib): Drug Safety Communication - FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns

Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq.

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