The Recall Desk
HighFDA (Devices)·Z-0916-2026·Announced 2025-12-17

[pending] Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

Pending LLM rewrite. Source: FDA_DEVICE Z-0916-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

The recalled product

Product
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Manufacturer
Datascope Corp.
Category
Medical Device — Devices

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 (16)

  • Model No. (UDI): D998-00-0800-31 (10607567109053)
  • D998-00-0800-32 (10607567111117)
  • D998-00-0800-33 (10607567109008)
  • D998-00-0800-35 (10607567109107)
  • D998-00-0800-36 (10607567114187)
  • D998-00-0800-45 (10607567108421)
  • D998-00-0800-52 (10607567108438)
  • D998-00-0800-53 (10607567108391)
  • D998-00-0800-55 (10607567108414)
  • D998-00-0800-65 (10607567113432)
  • D998-UC-0800-31 (10607567109053)
  • D998-UC-0800-33 (10607567109008)
  • D998-UC-0800-52 (10607567108438)
  • D998-UC-0800-53 (10607567108391)
  • D998-UC-0800-55 (10607567108414)
  • ALL SERIAL NO.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category