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

Hybrid balloon pumps recalled with a revised preventative maintenance schedule

Datascope is recalling 11,470 Cardiosave Hybrid Intra-Aortic Balloon Pump systems to issue an instructions for use addendum revising the preventative maintenance schedule.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: Scored 1 under the documentation criterion: the action issues a revised maintenance schedule in the instructions and identifies no product defect.

Plain-English summary

The Cardiosave Hybrid Intra-Aortic Balloon Pump system from Datascope Corp. is the subject of a recall action.

The instructions for use addendum revises the preventative maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

The record lists 11,470 units across model numbers including D998-00-0800-31, D998-00-0800-32 and D998-00-0800-33, with UDIs listed in the enforcement record. Distribution was nationwide domestically and to a wide range of other countries. The FDA has classified the action as Class II.

The enforcement record describes a documentation update aligning the instructions with the service manual rather than a product defect, and reports no injuries. Facilities should follow Datascope's instructions.

The recalled product

Product
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Manufacturer
Datascope Corp.
Category
Medical Device — Balloon pump
Hazard
Affected units
11,470

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.

Part of a larger recall action

This product is one of 2 recalled by Datascope Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Datascope Corp.

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Same hazard · documentation

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