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Class I Correction for Abiomed Impella Inaccurate Flow Readings

by Bruce Waldon | Apr 6, 2026 | Alerts, Alerts-Device, Cardiovascular, Implantable Devices, Industry News, Med-Devices, Product Corrections, US-FDA

FDA Class I Recall Abiomed Impella RP heart pumps Home About Consumer News Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact Abiomed Impella RP:...

Device Recall Alert: Edwards Lifesciences Arterial Cannula

by MDP Staff | Jul 24, 2025 | Alerts, Alerts-Device, Cannula, Cardiovascular, Class I Recalls, Med-Devices, Product Recalls

Recall Alert: Edwards Lifesciences Arterial Cannulae Risk of wire exposure near the cannula tip Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Edwards Lifesciences Arterial CannulaSource: FDA...

FDA Cracks Down on Insightra Medical

by MDP Staff | Jul 16, 2025 | Alerts, Cardiovascular, Device Warning Letters, FDA Enforcement, FDA Public Information, FDA Warning letters, Industry News, Med-Devices, QSR, Safety

FDA Cracks Down on Insightra Medical Unapproved use and serious quality violations found Home About Consumer Medical Devices Pharma AI Regulatory Quality QMSR Central News Enforcement Alerts Innovation Contact Warning Letter Cites a Number of Serious Violations In a...

Mechanical Circulatory Support (MCS) Devices

by Devices and Pharma | Jul 10, 2025 | Cardiovascular, Implantable Devices, Industry Information, Med-Devices, Products_Devices

Mechanical Circulatory Support (MCS) Devices Product family overview Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Overview of MCS Devices Mechanical Circulatory...

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