The Recall Desk
SevereFDA (Devices)·Z-0336-2022·Announced 2021-12-22

Cardiosave Hybrid IntraAortic Balloon Pump Recall Due to Fluid Ingress Risk

Datascope Corp. is recalling Cardiosave Hybrid IntraAortic Balloon Pumps due to the risk of fluid entering the device, which could cause system failure and hemodynamic instability.

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: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls never score below 4. While no deaths or reported serious injuries are documented in the source, the potential for system failure leading to hemodynamic instability represents significant patient risk.

Plain-English summary

Datascope Corp. is recalling multiple models of the Cardiosave Hybrid IntraAortic Balloon Pump (models 0998-00-0800-31 through 0998-UC-0800-65, all serial numbers). The recall addresses the possibility that fluid could enter the device.

If fluid enters the pump, it may cause short circuits in the electronic components, leading to system shutdown. This could result in unsafe hemodynamic instability—a serious condition affecting blood flow that requires immediate medical intervention.

The affected pumps have been distributed worldwide, including nationwide in the United States. A total of 5,566 units were distributed in the US, and an additional 6,354 units were distributed internationally.

Patients using this device or their healthcare providers should contact Datascope Corp. for additional information about this recall and any necessary corrective actions.

The recalled product

Product
Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-UC-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-UC-0800-34, 0998-00-0800-35, 0998-UC-0800-35, 0998-00-0800-36, 0998-UC-0800-36, 0998-00-0800-45,
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Device
Hazard
  • fluid-ingress
  • electrical-short
  • system-failure
  • hemodynamic-instability

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-UC-0800-31
  • 0998-00-0800-32
  • 10607567111117
  • 0998-UC-0800-32
  • 0998-00-0800-33
  • 10607567109008
  • 0998-UC-0800-33
  • 0998-00-0800-34
  • 10607567111940
  • 0998-UC-0800-34
  • 0998-00-0800-35
  • 10607567109107
  • 0998-UC-0800-35
  • 0998-00-0800-36
  • 10607567114187
  • 0998-UC-0800-36
  • 0998-00-0800-45
  • 10607567108421

Distribution

Distributed nationwide across the United States.

Related recalls

Same category