Balloon pump systems recalled with a revised preventative maintenance schedule
Datascope is recalling 47 Cardiosave Rescue 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 Rescue 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 47 units, model number 0998-00-0800-83 with UDI 10607567108407, covering all serial numbers. 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 Rescue. Intra-Aortic Balloon Pump system.
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Balloon pump
- Affected units
- 47
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 (2)
- Model No. (UDI): 0998-00-0800-83 (10607567108407)
- 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.
See all →- ModerateCardiosave battery charging station left bay screw prevents full battery insertion
FDA (Devices) · 2026-03-25
- ModerateDatascope CS100 balloon pump manual recalled for outdated battery specifications
FDA (Devices) · 2026-03-11
- ModerateDatascope CS300 balloon pump manual recalled for outdated battery specifications
FDA (Devices) · 2026-03-11
- LowBalloon pump instructions updated to reference the correct vibration standards
FDA (Devices) · 2025-12-24
- LowRescue balloon pump instructions updated to reference the correct vibration standards
FDA (Devices) · 2025-12-24
Same hazard · documentation
See all →- ModerateDEX Ophthalmic Tissue Forceps recalled for instructions update
FDA (Devices) · 2026-05-13
- LowExtra large newborn monitor caps recalled over an incorrect sizing guide
FDA (Devices) · 2026-02-18
- LowNewborn monitor caps recalled over an incorrect sizing guide on labeling
FDA (Devices) · 2026-02-18
- LowLarge newborn monitor caps recalled over an incorrect sizing guide
FDA (Devices) · 2026-02-18
- LowSmall newborn monitor caps recalled over an incorrect sizing guide
FDA (Devices) · 2026-02-18