Datascope Recalls Low Level Output Cables for Intra-Aortic Balloon Pumps
Datascope Corp. is recalling seven low level output cables for intra-aortic balloon pumps because they were packaged with incorrect cables.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a packaging error (incorrect cable) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Datascope Corp. is recalling seven units of the Low Level Output Cable - Interface to Philips Monitor, Part Number 0012-00-1589-03. These cables are designed for use with Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs).
The recall was initiated because one lot of the product was received from the supplier with an incorrect cable in the packaging. The affected units were distributed to California, Georgia, and Texas.
Healthcare facilities and consumers should stop using the affected cables and contact Datascope Corp. for further instructions or a replacement.
The recalled product
- Product
- Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03
- Manufacturer
- Datascope Corp.
- Category
- Medical Device — Cardiovascular
- Affected units
- 7
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 (1)
- 10000493876
Distribution
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