Balloon pump instructions updated to reference the correct vibration standards
Datascope is recalling 11,470 Cardiosave Hybrid units to issue an instructions for use addendum updating the Vibration and Shock Table to reference the correct standards.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 Hybrid 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 11,470 units, of which 5,095 are in the United States and 6,375 outside it, across models including 0998-00-0800-31 and 0998-00-0800-32 with the UDI-DIs listed in the enforcement record, 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 Hybrid
- 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 (20)
- 1) Model: 0998-00-0800-31
- UDI-DI: 10607567109053
- Serial Numbers: All
- 2) Model: 0998-00-0800-32
- UDI-DI: 10607567111117
- 3) Model: 0998-00-0800-33
- UDI-DI: 10607567109008
- 4)Model: 0998-00-0800-35
- UDI-DI: 10607567109107
- 5)Model: 0998-00-0800-36
- UDI-DI: 10607567114187
- 6)Model: 0998-00-0800-45
- UDI-DI: 10607567108421
- 7)Model: 0998-00-0800-52
- UDI-DI: 10607567108438
- 8)Model: 0998-00-0800-53
- UDI-DI: 10607567108391
- 9) Model: 0998-00-0800-55
- UDI-DI: 10607567108414
- 10) Model: 0998-00-0800-65
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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