System, Balloon, Intra-Aortic And Control

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-03-19Open, ClassifiedUnder Investigation by firm

  Battery Charging Station; Model: 0998-00-0802;

  The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.

• 2026-03-03Open, ClassifiedUnder Investigation by firm

  CS100 IABP. Software Version CS100 IABP Q.01.

  The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

• 2026-03-03Open, ClassifiedUnder Investigation by firm

  CS300 IABP. Software Version CS300 IABP C.01.

  The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.

• 2025-12-16Open, ClassifiedProcess change control

  Cardiosave Hybrid

  The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

• 2025-12-16Open, ClassifiedProcess change control

  Cardiosave Rescue

  The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

• 2025-12-11Open, ClassifiedComponent design/selection

  Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

  The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

• 2025-12-11Open, ClassifiedComponent design/selection

  Cardiosave Rescue. Intra-Aortic Balloon Pump system.

  The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

• 2025-08-13TerminatedNo Marketing Application

  Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available with either a 40, 35, 30, 25, or 20 cc balloon. The catheter has two lumens and is designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon. The inner lumen is used for a guidewire and blood pressure measurement. It is packaged as a convenience kit with accessories (one-way valve, 50 cc syringe, guide wires, introducer needle, dilator, pressure tubing, Datascope & Arrow adaptors). The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium Component: No

  Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.

• 2024-11-05Open, ClassifiedError in labeling

  MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

  There is discrepant labeling on the inner and outer packaging of the device.

• 2024-09-20Open, ClassifiedSoftware design

  CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.

  Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.