CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179

Class I - Dangerous

🏥 Medical Devices Recalled: May 3, 2018 Maquet Datascope Corp - Cardiac Assist Division Infusion Pumps Nationwide

What Should You Do?

Check if you have this product:
All Serial Numbers distributed from 03/06/2012 to 04/26/2018
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Maquet Datascope Corp - Cardiac Assist Division
Reason for Recall:: Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179

Product Codes/Lot Numbers:

All Serial Numbers distributed from 03/06/2012 to 04/26/2018

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1928-2018

Related Recalls

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

Maquet Datascope Corp - Cardiac Assist Division

Class I - Dangerous

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

Sep 20, 2018 Other Medical Devices Nationwide View Details →

Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

Maquet Datascope Corp - Cardiac Assist Division

Class I - Dangerous

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

Sep 20, 2018 Other Medical Devices Nationwide View Details →

CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

Maquet Datascope Corp - Cardiac Assist Division

Class I - Dangerous

False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.

Jul 17, 2017 Patient Monitors Nationwide View Details →