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Devices

Mar 14, 2022

A list of recent recalls on devices
 

  • 2022-03-14 SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) by Baxter: Class I Recall - Due to the risk of not alarming for repeated upstream occlusion events [FDA]
     
  • 2022-03-09 TurboHawk Plus Directional Atherectomy System by Medtronic: Class I Recall - Due to Risk of Tip Damage During Use [FDA]
     
  • 2022-02-24 Arrow -Trerotola Percutaneous Thrombolytic Device by Arrow International: Class I Recall - Due to Risk of Tip Damage During Use [FDA]
     
  • 2022-02-18 bellavista 1000 and 1000e Series Ventilators by Vyaire Medical: Class I Recall - Due to Issues with Software Configurations [FDA]
     
  • 2022-01-13 Destino Twist Steerable Guiding Sheath by Oscor: Recall - Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use[FDA]
     
  • 2022-01-10 WIRION Embolic Protection Device by Cardiovascular Systems: Class I Recall - Due to Complaints of Filter Breakage During Retrieval [FDA]
     
  • 2022-01-07 Synergy Cranial and StealthStation S7 Cranial Software by Medtronic: Class I Recall - Due to Potential Risk of Inaccurate Biopsy Depth Gauge Cycle View [FDA]
     
  • 2022-01-05 Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) by Getinge/Datascope/Maquet: Class I Recall - Due to Reports of Fluid Leaks [FDA]
     
  • 2022-01-04 Puritan Bennett 980 Series Ventilator by Covidien: Class I Recall - Due to Manufacturing Assembly Error [FDA]