Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications
Datascope is recalling 2,714 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use are missing the Contraindications section.
What this means for you
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: The recall is classified as FDA Class II. The hazard is a documentation error (missing contraindications section) rather than a physical defect or contamination, which aligns with the 'Moderate' severity criteria for labeling/documentation issues.
Plain-English summary
Datascope Corporation is recalling 2,714 units of the Mega Intra-Aortic Balloon (IAB) Catheter, 7.5FR 40cc. The recall was initiated because the U.S. Instructions for Use (IFU) for the device were missing the Contraindications section.
The affected products are identified by the codes 0684 00 0295 01U and 0684 00 0295 02U. These devices were distributed nationwide in the United States. The intra-aortic balloon catheter is used to provide counterpulsation therapy in the aorta to increase blood supply to the heart muscle and decrease the work of the left ventricle.
Healthcare providers and facilities should check their inventory for the specific product codes listed above. Users should refer to the manufacturer for further instructions regarding the missing documentation.
The recalled product
- Product
- Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the hear
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 2,714
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)
- 0684 00 0295 01U and 0684 00 0295 02U
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Datascope Corporation 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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