Datascope Recalls Linear Intra-Aortic Balloon Catheter for Labeling Error
Datascope Corporation is recalling Linear 7.5 FR 40cc Intra-Aortic Balloon Catheters due to a duplicate serial number label detected during label reconciliation.
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: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error.
Plain-English summary
Datascope Corporation is recalling one unit of the LINEAR 7.5 FR. 40cc IAB Catheter manufactured by Maquet Getinge Group. The recall was initiated after a duplicate serial number label was detected during a label reconciliation process.
The affected product is identified by Part Number 0684-00-0480-01U. The distribution pattern for this specific unit was limited to Texas (TX). The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare facilities and distributors should stop using the affected catheter and contact Datascope Corporation for further instructions regarding the return or disposal of the unit. This recall addresses a documentation and labeling integrity issue rather than a defect in the physical device itself.
The recalled product
- Product
- LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
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)
- Part Number - 0684-00-0480-01U
Distribution
Distributed in 1 state:
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