Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx
- 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:
- Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Product Codes/Lot Numbers:
IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1523-2014
Related Recalls
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Maquet Datascope Corp - Cardiac Assist Division
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.
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Maquet Datascope Corp - Cardiac Assist Division
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.
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
Maquet Datascope Corp - Cardiac Assist Division
Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.