The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2431-2023·Announced 2023-09-06

Cardiosave Hybrid Intra-Aortic Balloon Pump charging issue recall

The Cardiosave Hybrid Intra-Aortic Balloon Pump console fails to charge if not fully inserted into the hospital cart. Users unaware of this requirement may attempt to use a non-charged device during critical cardiac care.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as Class I, requiring a minimum severity score of 4. While no deaths or serious injuries are documented in the source text, this recall affects a critical cardiac care device. A failure to charge could prevent the device from functioning when needed in critical patient care situations.

Plain-English summary

The Cardiosave Hybrid Intra-Aortic Balloon Pump, manufactured by Datascope Corp., is being recalled. The recall affects 9,175 units distributed nationwide and includes multiple models affecting all lot numbers.

Users reported that the device was not charging as expected. Investigation found that users were unaware that the console must be fully inserted into the hospital cart for charging to occur. If the console is not fully inserted, the batteries will not charge.

Healthcare facilities and users should ensure the console is fully inserted into the cart before clinical use. For additional guidance, consult the FDA recall notice or contact Datascope Corp. directly.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 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, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53…
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Care
Hazard
Affected units
9,175

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)

  • All Lot Numbers. Model: 0998-00-0800-31
  • UDI: 10607567109053
  • Model: 0998-UC-0800-31
  • UDI: N/A
  • Model: 0998-00-0800-32
  • UDI: 10607567111117
  • Model: 0998-00-0800-33
  • UDI: 10607567109008
  • Model: 0998-UC-0800-33
  • Model: 0998-00-0800-34
  • UDI: 10607567111940
  • Model: 0998-00-0800-35
  • UDI: 10607567109107
  • Model: 0998-00-0800-45
  • UDI: 10607567108421
  • Model: 0998-00-0800-52
  • UDI: 10607567108438
  • Model: 0998-UC-0800-52
  • Model: 0998-00-0800-53
  • UDI:10607567108391

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Datascope Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same manufacturer · Datascope Corp.

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