The Recall Desk
SevereFDA (Devices)·Z-3134-2024·Announced 2024-10-02

Cardiosave hybrid IABP software defect poses hemodynamic instability and data loss risk

Datascope's Cardiosave Hybrid IABP devices carry a risk of hemodynamic instability and clinical data transmission failure due to a software defect. Datascope has developed a software correction (Revision D.00) to mitigate this risk.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall of critical cardiac device with software defect. The classification as FDA Class I requires a minimum severity of 4 per regulatory framework. The defect poses risk of hemodynamic instability and data transmission failure, but no injuries or deaths are reported.

Plain-English summary

The FDA is recalling the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) manufactured by Datascope Corp. The device is used to inflate and deflate intra-aortic balloons and has been distributed to more than 50 countries, affecting approximately 5,475 units.

A software defect in the device poses a risk of hemodynamic instability and failure of clinical data transmission. Hemodynamic instability can compromise cardiac function in patients, while data transmission failure may prevent essential clinical information from reaching healthcare providers.

Datascope has developed a software correction (Revision D.00) to mitigate these risks. Affected healthcare facilities should contact Datascope for guidance on implementing this correction.

The recalled product

Product
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac / Intra-aortic Balloon Pump
Hazard
  • hemodynamic-instability
  • clinical-data-transmission-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Product No. 0998-00-0800-31
  • 0998-UC-0800-31
  • 0998-00-0800-32
  • 0998-00-0800-33
  • 0998-UC-0800-33
  • 0998-00-0800-34
  • 0998-00-0800-35
  • 0998-00-0800-36
  • 0998-00-0800-45
  • 0998-00-0800-52
  • 0998-UC-0800-52
  • 0998-00-0800-53
  • 0998-UC-0800-53
  • 0998-00-0800-55
  • 0998-UC-0800-55
  • 0998-00-0800-65
  • UDI: 10607567109053
  • 10607567111117
  • 10607567109008
  • 10607567111940

Distribution

Distribution scope not specified by the agency.

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