The Recall Desk
SevereFDA (Devices)·Z-1145-2023·Announced 2023-03-15

Cardiosave Hybrid IABP Devices Recalled for Unexpected Shutdown Risk

Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to a connection failure that may cause unexpected shutdown during use. The failure prevents communication between the device's display head and base unit.

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. Although no deaths or injuries are reported in the source text, FDA Class I recalls carry a minimum severity of 4 per the rubric. The unexpected shutdown of a critical cardiac support device poses significant risk of serious adverse health consequences.

Plain-English summary

Datascope Corp. is recalling 4,062 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP) with coiled cord cable (part number 0012-00-1801). The IABP is a cardiac support device.

The recall was initiated because a failure of the connection between the coiled cord cable and the cable assembly backplane prevents proper communication between the display head and base unit, which may lead to unexpected shutdown. An unexpected shutdown of the device during use could have serious health consequences.

The affected models include 0998-00-0800-31, 32, 33, 34, 35, 45, 52, 53, 55, 65 and UC variants (0998-UC-0800-31, 33, 52, 53), with all serial numbers affected. The devices were distributed worldwide.

Healthcare facilities and anyone with these devices should contact Datascope Corp. or the FDA with questions about repair, replacement, or continued safe use of the device.

The recalled product

Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support
Hazard
  • unexpected-shutdown
  • connection-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)

  • All serial numbers. Model 0998-00-0800-31
  • UDI-DI 10607567109053
  • Model 0998-00-0800-32
  • UDI-DI 10607567111117
  • Model 0998-00-0800-33
  • UDI-DI 10607567109008
  • Model 0998-00-0800-34
  • UDI-DI 10607567111940
  • Model 0998-00-0800-35
  • UDI-DI 10607567109107
  • Model 0998-00-0800-45
  • UDI-DI 10607567108421
  • Model 0998-00-0800-52
  • UDI-DI 10607567108438
  • Model 0998-00-0800-53
  • UDI-DI 10607567108391
  • Model 0998-00-0800-55
  • UDI-DI 10607567108414
  • Model 0998-00-0800-65
  • UDI-DI 10607567113432

Distribution

Distributed nationwide across the United States.

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