Intra-Aortic Balloon Pump (IABP) FDA Alerts

Class 1 Recall: Maquet Datascope Corp./Getinge Group Recalls the CARDIOSAVE Hybrid Intra-aortic Balloon Pump due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy

Class 1 Recall: Edwards Lifesciences LLC. Recalls Certitude Delivery System Due to Mold Overflow Defect Which May Obstruct Blood Flow

Class 1 Recall: Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to Risk of Valve Failure Preventing Balloon Inflation and Deflation

Class 1 Recall: Arrow International Inc. Recalls Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Due to Sheath Separation Issue