Intra-Aortic Balloon Pumps Fiber Optic Sensor Input Failure Recalled
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps because users reported failure of the fiber optic sensor input when inserting the balloon connector. This could affect proper device operation.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries, illnesses, or deaths. Because no harm has been reported despite the identified sensor failure risk, this meets the 'High' severity criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85. Approximately 9,379 units are affected across all lot numbers.
The recalled devices experience a failure in the intra-aortic balloon fiber optic sensor input when inserting the fiber optic connector. Users have reported this failure during connector insertion, which could impact proper device operation.
These devices are distributed nationwide in the United States and globally for use as cardiac support equipment in clinical settings.
The recalled product
- Product
- Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- Manufacturer
- Datascope Corp.
- Hazard
- Affected units
- 9,379
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 (6)
- All Lot Numbers. Model: 0998-00-0800-75
- UDI: 10607567112312
- Model: 0998-00-0800-83
- UDI: 10607567108407
- Model: 0998-00-0800-85
- UDI: 10607567113449
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
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