Articles by n8n Publisher

FDA Updates Bard Peripheral Atherectomy Catheter Alert: Key Compliance Lessons for Device Manufacturers

FDA Updates Bard Peripheral Atherectomy Catheter Alert: Key Compliance Lessons for Device Manufacturers

By n8n Publisher |

FDA's updated alert on Bard atherectomy catheters signals new recall communication standards. Learn what manufacturers…

FDA Early Alert: BD Infusion Set Performance Issues Signal New Recall Communication Strategy

FDA Early Alert: BD Infusion Set Performance Issues Signal New Recall Communication Strategy

By n8n Publisher |

FDA issues Early Alert for BD infusion set issues as part of new Communications Pilot,…

FDA Early Alert: Boston Scientific Defibrillation Lead Safety Issue Under Enhanced Recall Program

FDA Early Alert: Boston Scientific Defibrillation Lead Safety Issue Under Enhanced Recall Program

By n8n Publisher |

FDA issues Early Alert on Boston Scientific defibrillation lead as part of enhanced recall communication…

2024 Medical Device Recalls: Key Trends and Compliance Lessons for Manufacturers

2024 Medical Device Recalls: Key Trends and Compliance Lessons for Manufacturers

By n8n Publisher |

2024 saw intensified regulatory scrutiny of medical device recalls. Learn key trends, compliance lessons, and…

Critical Medical Device Recalls in May 2025: What Manufacturers Must Know

Critical Medical Device Recalls in May 2025: What Manufacturers Must Know

By n8n Publisher |

May 2025 medical device recalls affected critical procedures including craniotomies and infant ventilation. Learn key…

April 2025 Medical Device Recalls Drop Significantly: Abbott HeartMate Accessory Recall Analysis

April 2025 Medical Device Recalls Drop Significantly: Abbott HeartMate Accessory Recall Analysis

By n8n Publisher |

April 2025 saw only one medical device recall - an Abbott HeartMate accessory. Learn why…

FDA Launches Pilot Program to Accelerate High-Risk Medical Device Recall Communications

FDA Launches Pilot Program to Accelerate High-Risk Medical Device Recall Communications

By n8n Publisher |

FDA's CDRH launches pilot program to speed recall communications for high-risk medical devices, requiring manufacturers…

Medical Device Recalls Hit Four-Year High in 2024: What Manufacturers Need to Know

Medical Device Recalls Hit Four-Year High in 2024: What Manufacturers Need to Know

By n8n Publisher |

Medical device recalls surged to a four-year high in 2024. Learn why this happened and…

FDA Updates Baxter Solution Set Recall: Key Lessons for Medical Device Manufacturing Quality Control

FDA Updates Baxter Solution Set Recall: Key Lessons for Medical Device Manufacturing Quality Control

By n8n Publisher |

FDA updates Baxter solution set recall as part of enhanced communications pilot. Learn key compliance…

FDA Early Alert: Baxter Infusion Pump Software Issue Highlights Critical Quality Control Needs

FDA Early Alert: Baxter Infusion Pump Software Issue Highlights Critical Quality Control Needs

By n8n Publisher |

FDA issues early alert on Baxter infusion pump software issue, highlighting critical software validation needs…

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