http://www.fda.gov/ en http://www.fda.gov/medical-devices/medical-device-recalls/baxter-healthcare-corporation-recalls-sigma-spectrum-infusion-pumps-master-drug-library-and-spectrum Software upgrades to the SIGMA Spectrum and Spectrum IQ infusion pumps are leading to an increase in false alarms for upstream occlusion. Tue, 01 Aug 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/baxter-healthcare-corporation-recalls-sigma-spectrum-infusion-pumps-master-drug-library-and-spectrum http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at t Mon, 31 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl http://www.fda.gov/medical-devices/letters-health-care-providers/2023-letters-health-care-providers The FDA posts letters to health care providers about the safe use of medical devices. Mon, 31 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/2023-letters-health-care-providers http://www.fda.gov/medical-devices/letters-health-care-providers/abbott-trifecta-valves-potential-risk-early-structural-valve-deterioration-letter-health-care Learn more about the issue, recommendations, FDA actions and reporting problems to the FDA Mon, 31 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/abbott-trifecta-valves-potential-risk-early-structural-valve-deterioration-letter-health-care http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls 2023 Medical Device Recalls Mon, 31 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-spectrum-v8-and-spectrum-iq-infusion-pumps-specific Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ infusion pumps in the U.S. and Puerto Rico that have been upgraded to software versions v8.01.01 and v9.02.01. The Correction is due to an increase in reported false upstream o Mon, 31 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-spectrum-v8-and-spectrum-iq-infusion-pumps-specific http://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-trusignal-spo2-sensors-issues-may-reduce-defibrillation-energy-expose-patients TruSignal sensors monitor SpO2 and pulse rate. Sensor issues may impact patient care delivery including defibrillation without care providers’ knowledge. Fri, 28 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-trusignal-spo2-sensors-issues-may-reduce-defibrillation-energy-expose-patients http://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-all-impella-left-sided-blood-pumps-risk-motor-damage-after-contact-transcatheter The motor housing of Impella blood pumps may come into contact with TAVR distal stents, causing damage to the motor blades and impacting pump flow. Thu, 27 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-all-impella-left-sided-blood-pumps-risk-motor-damage-after-contact-transcatheter http://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-amplatzer-steerable-delivery-sheath-increased-risk-air-embolism Abbott’s Amplatzer Steerable Delivery Sheath, a cardiac catheter, is being recalled for an increased risk of air embolism. Wed, 26 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-amplatzer-steerable-delivery-sheath-increased-risk-air-embolism http://www.fda.gov/medical-devices/letters-health-care-providers/intended-use-imaging-software-intracranial-large-vessel-occlusion-letter-health-care-providers The U.S. Food and Drug Administration (FDA) wants to increase awareness about the intended use of imaging software for intracranial large vessel occlusion or LVO. Wed, 26 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/intended-use-imaging-software-intracranial-large-vessel-occlusion-letter-health-care-providers http://www.fda.gov/medical-devices/medical-device-recalls/megadyne-recalls-mega-2000-and-mega-soft-reusable-patient-return-electrodes-risk-serious-burn MEGA Patient Return Electrodes used during monopolar electrosurgery may cause serious burn injuries to patients. Fri, 21 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/megadyne-recalls-mega-2000-and-mega-soft-reusable-patient-return-electrodes-risk-serious-burn http://www.fda.gov/medical-devices/letters-health-care-providers/use-alternative-testing-method-quidel-cardiovascular-inc-quidel-triage-cardiac-panel-letter-health The test is used to help doctors quickly diagnose when someone is experiencing a heart attack and other life-threatening injuries to the heart muscle. Wed, 19 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/use-alternative-testing-method-quidel-cardiovascular-inc-quidel-triage-cardiac-panel-letter-health http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-implantable-cardioverter-defibrillators-icds-and-cardiac-resynchronization-therapy Medtronic Recalls ICDs and CRT-Ds for Risk of Low or No Energy Output Tue, 18 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-implantable-cardioverter-defibrillators-icds-and-cardiac-resynchronization-therapy http://www.fda.gov/medical-devices/medical-device-recalls/quidel-cardiovascular-inc-recalls-quidel-triage-cardiac-panels-risk-false-negative-troponin-results QuidelOrtho Recalls Triage Cardiac Panels for False Negative Troponin Results Mon, 17 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/quidel-cardiovascular-inc-recalls-quidel-triage-cardiac-panels-risk-false-negative-troponin-results http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications Listing of Medical Device 2023 Safety Communications Mon, 17 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/2023-safety-communications http://www.fda.gov/medical-devices/safety-communications/do-not-use-royalvibe-health-cellquicken-or-well-being-reality-ultrasound-medical-devices-fda-safety RoyalVibe Health, CellQuicken, and Well-Being Reality medical devices are not authorized for marketing and have not been shown to be safe or effective. Mon, 17 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/safety-communications/do-not-use-royalvibe-health-cellquicken-or-well-being-reality-ultrasound-medical-devices-fda-safety http://www.fda.gov/medical-devices/medical-device-recalls/draeger-medical-recalls-oxylog-3000-plus-emergency-and-transport-ventilators-risk-unexpected The Oxylog 3000 Plus battery may drain and stop providing required breathing support even when the ventilator is plugged into AC power. Thu, 13 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/draeger-medical-recalls-oxylog-3000-plus-emergency-and-transport-ventilators-risk-unexpected http://www.fda.gov/medical-devices/medical-device-recalls/noxbox-ltd-recalls-noxboxi-nitric-oxide-system-manifold-failure-may-cause-gas-leaks-and-interrupt NOxBOXi delivers inhaled nitric oxide therapy to neonates. If the manifold fails, therapy may be interrupted and the patient may experience oxygen desaturation. Thu, 13 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/medical-device-recalls/noxbox-ltd-recalls-noxboxi-nitric-oxide-system-manifold-failure-may-cause-gas-leaks-and-interrupt http://www.fda.gov/medical-devices/letters-health-care-providers/update-paclitaxel-coated-devices-treat-peripheral-arterial-disease-unlikely-increase-risk-mortality Available data no longer supports a probable late mortality risk associated with paclitaxel-coated devices used to treat femoropopliteal disease. Tue, 11 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/update-paclitaxel-coated-devices-treat-peripheral-arterial-disease-unlikely-increase-risk-mortality http://www.fda.gov/medical-devices/letters-health-care-providers/illumina-cybersecurity-vulnerability-affecting-universal-copy-service-software-may-present-risks Illumina cybersecurity vulnerability affecting the Universal Copy Service software may impact patient health results. Fri, 07 Jul 2023 00:00:00 EDT FDA http://www.fda.gov/medical-devices/letters-health-care-providers/illumina-cybersecurity-vulnerability-affecting-universal-copy-service-software-may-present-risks