FDA Class I Recall for Abiomed Impella Gen 1 Purge Cassettes

by | Apr 6, 2026 | Alerts, Alerts-Device, Class I Recalls, FDA Public Information, MedWatch-System, Product Recalls, Products_Devices, Reg_Products, Safety, US-FDA

FDA Class I Recall Abiomed Impella heart pumps cassettes 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 Medical...

When a Small Process Failure Becomes a Patient Safety Event

by | Mar 23, 2026 | Analysis, Editorial, ISO 14971, Med-Devices, Product Design, Product Quality, Products_Devices, QMSR, Quality system, Reg_Information, Reg_Products, US-FDA

Medical Device Safety Alert Erbe cryoprobes may rupture or burst Home About Consumer Food and Beverage Supplements Regulatory Medical Devices Pharma Biologics Combination Products Veterinary AI Quality QMSR Central News Enforcement Alerts Innovation Contact What the...