Rescue balloon pump instructions updated to reference the correct vibration standards
Datascope is recalling 47 Cardiosave Rescue units to issue an instructions for use addendum updating the Vibration and Shock Table to reference the correct standards.
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 corrects a reference table in the instructions and identifies no product defect.
Plain-English summary
The Cardiosave Rescue from Datascope Corp. is the subject of a recall action.
The instructions for use addendum updates the Vibration and Shock Table to reference the correct standards.
The record lists 47 units, of which 44 are in the United States and 3 outside it, under model 0998-00-0800-83 with UDI-DI 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 III, its least serious category.
The enforcement record describes a documentation correction rather than a product defect, and reports no injuries. Facilities should follow Datascope's instructions.
The recalled product
- Product
- Cardiosave Rescue
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Balloon pump
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 (3)
- Model: 0998-00-0800-83
- UDI-DI: 10607567108407
- Serial Numbers: All
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.
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