The Recall Desk
SevereFDA (Devices)·Z-0885-2023·Announced 2023-01-25

Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly

The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.

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 classification mandates a minimum severity of Severe. The device may shut down unexpectedly during therapy, with no reported deaths or injuries documented.

Plain-English summary

The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), manufactured by Datascope Corp., is being recalled because the device may shut down unexpectedly when blood enters it during therapy if the intra-aortic balloon catheter is compromised. Unexpected shutdown during therapy could disrupt the cardiac support being provided.

The recall affects 11,906 total units of the Cardiosave Hybrid IABP distributed worldwide, including throughout the United States and internationally. Affected devices span multiple models in the 0998-00-0800 and 0998-UC-0800 series.

Healthcare facilities using affected devices should verify their equipment using the provided model numbers. Report any unexpected shutdowns or device malfunctions to Datascope Corp. and the FDA.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-08
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Equipment
Hazard
  • device-shutdown
  • blood-entry
  • catheter-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)

  • UDI-DI: 0998-00-0800-31
  • 10607567109053
  • 0998-00-0800-32
  • 10607567111117
  • 0998-00-0800-33
  • 0998-00-0800-34
  • 10607567111940
  • 0998-00-0800-35
  • 10607567109107
  • 0998-00-0800-36
  • 10607567114187
  • 0998-00-0800-45
  • 10607567108421
  • 0998-00-0800-52
  • 10607567108438
  • 0998-00-0800-53
  • 10607567108391
  • 0998-00-0800-55
  • 10607567108414
  • 0998-00-0800-65

Distribution

Distributed nationwide across the United States.

Related recalls

Same category