🔍 RecallPedia

CS 100 Intra-Aortic Balloon Pump

Class I - Dangerous
🏥 Medical Devices Recalled: June 16, 2017 Maquet Datascope Corp - Cardiac Assist Division Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    0998-XX-3013-XX, 0998-UC-3013-XX
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

CS 100 Intra-Aortic Balloon Pump

Product Codes/Lot Numbers:

0998-XX-3013-XX, 0998-UC-3013-XX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2737-2017

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 →