Murilo Freitas – Page 8

Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft

Murilo Freitas - 05:00, 22 de December de 2025379

Cook Medical is removing certain ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT proximal components because PTFE scrapings may enter the stent graft during deployment.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/endovascular-graft-recall-cook-medical-removes-zenith-alpha-2-thoracic-endovascular-graft

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MRI System Correction: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems

Murilo Freitas - 05:00, 22 de December de 2025197

Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/mri-system-correction-siemens-healthineers-issues-correction-3-tesla-mri-systems

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Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts

Murilo Freitas - 05:00, 22 de December de 2025247

Drager is removing affected ErgoStar Cather Mounts due to cracks in the hose.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/catheter-mount-recall-draeger-removes-ergostar-catheter-mounts

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Cardiac Cannula Recall: Medtronic Removes DLP Left Heart Vent Catheter

Murilo Freitas - 05:00, 21 de December de 2025386

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/cardiac-cannula-recall-medtronic-removes-dlp-left-heart-vent-catheter

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Microbore Extension Set Recall: B. Braun Medical Inc. Removes Microbore Extension Sets

Murilo Freitas - 05:00, 21 de December de 2025215

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/microbore-extension-set-recall-b-braun-medical-inc-removes-microbore-extension-sets

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Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pumps

Murilo Freitas - 05:00, 21 de December de 2025247

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/infusion-pump-correction-baxter-issues-correction-novum-iq-large-volume-pumps

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FDA Grants Two National Priority Vouchers

Murilo Freitas - 20:16, 18 de December de 2025176

FDA Grants Two National Priority Vouchers
http://www.fda.gov/news-events/press-announcements/fda-grants-two-national-priority-vouchers

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FDA Explores New Contracting Approach to Advance Public Health Innovation

Murilo Freitas - 15:02, 18 de December de 2025179

FDA Explores New Contracting Approach to Advance Public Health Innovation
http://www.fda.gov/news-events/press-announcements/fda-explores-new-contracting-approach-advance-public-health-innovation

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Update on the Safety of Andexxa by AstraZeneca: FDA Safety Communication

Murilo Freitas - 05:00, 18 de December de 2025315

Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic

http://www.fda.gov/safety/medical-product-safety-information/update-safety-andexxa-astrazeneca-fda-safety-communication

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Olympus Announces Voluntary Corrective Action for the Single-Use Ligating Device

Murilo Freitas - 05:00, 17 de December de 2025142

Center Valley, Pa., (December 5, 2025)-Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device (“Polyloop”) following identification of a potential safety issue.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-announces-voluntary-corrective-action-single-use-ligating-device