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Abbott/Thoratec Recalls HeartMate II and HeartMate 3 LVAS

by Bruce Waldon | Apr 21, 2024 | Alerts, Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls, Product Safety, US-FDA

Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate 3 Biological material buildup may obstruct flow Home About Consumer Medical Devices Pharma AI Regulatory Quality News Enforcement Alerts Innovation Contact Recall Alert: HeartMate II and HeartMate 3 Left...

Fresenius Kabi Recalls Ivenix Infusion Pump Software 

by Bruce Waldon | Apr 17, 2024 | Alerts, Alerts-Device, Class I Recalls, Med-Devices, Product Recalls, Product Safety

Fresenius Kabi Recalls Ivenix Infusion Pump Software Software anamolies could cause patient harm and fatalities Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact...

Urgent Recall for Boston Scientific Obsidio Conformable Embolic 

by Bruce Waldon | Apr 17, 2024 | Alerts, Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls

Urgent Recall Notice for Boston Scientific Obsidio Conformable Embolic Increased bowel ischemia risk with lower GI bleeding Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation...

Medos International Recalls CEREBASE DA Guide Sheath 

by Bruce Waldon | Apr 17, 2024 | Alerts, Alerts-Device, Class I Recalls, Consumer Safety, Med-Devices, Product Recalls, Product Safety

Medos International Recalls CEREBASE DA Guide Sheath Due to cracking of its distal catheter shaft Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Urgent Class I...

Asensus Surgical Inc Issues Recall for Senhance Surgical System 

by Bruce Waldon | Apr 16, 2024 | Alerts, Alerts-Device, Class I Recalls, Med-Devices, Product Recalls

Asensus Surgical Recalls Senhance Surgical System Malfunctions with Robotic Surgical Device Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation Contact Class I Recall Notice  ...

Datex-Ohmeda Issues Field Correction for EVair Air Compressors 

by Bruce Waldon | Apr 15, 2024 | Alerts, Alerts-Device, Class I Recalls, Med-Devices, MedWatch-System, Product Recalls, Product Safety

Datex-Ohmeda Issues Field Correction for EVair Air Compressors Formaldehyde emissions when used with certain ventilators Home About Consumer Regulatory Medical Devices Pharma Biologics Combination Products AI Quality QMSR Central News Enforcement Alerts Innovation...
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