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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 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.
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