The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2435-2023·Announced 2023-09-06

Intra-Aortic Balloon Pumps recalled for unexpected gas loss and gain alarms

Datascope's Cardiosave Hybrid Intra-Aortic Balloon Pumps may trigger unexpected alarms indicating gas loss or gain due to undocumented causes including patient movement and blood in the circuit. The FDA Class I recall affects 9,175 units.

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: This is an FDA Class I recall, which mandates a minimum severity score of 4 per the guidance rules. Although the source text does not explicitly report patient illnesses or injuries, the regulatory classification indicates serious potential for patient harm from unexpected device behavior in a critical care setting.

Plain-English summary

Datascope Corp. is recalling 9,175 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) units, including multiple part numbers across all lot numbers. These devices support heart function in critical cardiac care settings.

Users reported instances of unexpected alarms reading 'Gas Loss in IAB Circuit' and 'Gas Gain in IAB Circuit' while therapy was being provided. An internal investigation determined that these alarms can be triggered by factors not documented in the device's instructions for use. Identified triggers include patient movement (coughing, general movement, and swallowing), blood present in the circuit, kinks and abrasions of tubing and catheter, and certain patient conditions. Additionally, hardware issues related to these alarms have been identified.

The devices were distributed worldwide with US nationwide distribution.

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 Support Device
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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