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

Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

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

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

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