Safety

CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy

[Posted 06/26/2018]

AUDIENCE:
Cardiology, Risk Management, Surgery

ISSUE: Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death. 

 CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.
  • Part Numbers: 0998-00-0800-XX & 0998-UC-0800-XX and cart 0997-00-1179 (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75)

  • Lot Numbers: All lots

  • Manufacturing Dates: December 12, 2011 to April 25, 2018

  • Distribution Dates: March 6, 2012 to April 26, 2018

BACKGROUND: The CARDIOSAVE Hybrid Intra-aortic Balloon Pump intra-aortic balloon pump is a cardiac assist device used with patients undergoing cardiac and non-cardiac surgery, and to treat patients with acute coronary syndrome or complications from heart failure.

RECOMMENDATION: Maquet Datascope Corp instructs users to:

  • Never place fluids on top of the unit

  • Ensure that the saline container and tubing do not hang directly over the IABP

  • In case of accidental spillage, to wipe clean immediately and have the unit serviced to ensure no hazard exists.

In case of an interruption in therapy, the letter instructed users to:

  • Transfer the patient to an alternative IABP   

  • If an alternative IABP is unavailable

    • manually inflate the IAB with air or helium and immediately aspirate

    • repeat every 5 minutes until either an alternate IABP is available or alternatively (i.e., if an alternative IABP is not available in a reasonable amount of time) the intra-aortic balloon catheter should be removed from the patient.

Affected customers will be contacted by Maquet Datascope Corp. to schedule on-site service of the IABP by a Maquet Datascope Corp. Sales or Service Representative. The company anticipates having the protective top cover available by late June 2018.

Customer in the U.S. looking for more information about this recall can contact Maquet Datascope Corp.’s Technical Support Department at 1-888-627-8383 (press option 3), Monday through Friday, between 8:00 am and 6:00 pm Eastern Standard Time.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[06/06/2018 - Medical Device Recall - FDA]

Page Last Updated: 06/06/2018
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