The Recall Desk
SevereFDA (Devices)·Z-1146-2023·Announced 2023-03-15

Cardiosave Rescue Intra-Aortic Balloon Pumps recalled for connection failure

Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a coiled cord cable connection failure that may cause unexpected device shutdown and loss of communication.

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 score of 4. The IABP is a critical care device for cardiac support; unexpected shutdown during use poses serious risk of patient harm. No deaths or serious injuries have been reported in the source material.

Plain-English summary

Datascope Corp. is recalling specific models of the Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)—Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85, all equipped with coiled cord cables (part number 0012-00-1801). This is an FDA Class I recall affecting approximately 4,062 units.

The coiled cord cable can fail at the connection point where it attaches to the cable assembly backplane. When this connection fails, communication between the display head and base unit is disrupted, causing the pump to shut down unexpectedly during patient use.

The affected devices have been distributed worldwide, including throughout the United States and to numerous international locations. Any healthcare facility using these devices should immediately take action.

Facilities should contact Datascope Corp. for device replacement or further service instructions. Do not operate affected devices until the connection issue has been resolved or the device has been replaced by the manufacturer.

The recalled product

Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Manufacturer
Datascope Corp.
Category
Medical Device — Cardiac Support Equipment
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 (6)

  • All serial numbers. Model Number 0998-00-0800-75
  • UDI-DI 10607567112312
  • Model Number 0998-00-0800-83
  • UDI-DI 10607567108407
  • Model Number 0998-00-0800-85
  • UDI-DI 10607567113449

Distribution

Distributed nationwide across the United States.

Related recalls

Same category