Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications
Datascope is recalling Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use were 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a labeling error (missing contraindications) rather than a physical defect in the device itself, and no injuries or illnesses are reported in the source text.
Plain-English summary
Datascope Corporation is recalling the Mega Intra-Aortic Balloon (IAB) Catheter, 8FR 50cc. The recall involves 12,744 units that were distributed nationwide in the United States. The affected products are identified by the codes 0684 00 0296 01U and 0684 00 0296 02U.
The recall was initiated because the U.S. Instructions for Use for the device were missing the Contraindications section. This omission means that healthcare providers may not have had access to critical safety information regarding conditions under which the device should not be used.
Healthcare providers and facilities should stop using the affected Mega Intra-Aortic Balloon Catheters and contact Datascope Corporation for instructions on how to return the products. Patients who have received this device should consult their healthcare provider if they have questions about their treatment.
The recalled product
- Product
- Intra-Aortic Balloon Catheter Mega 8FR 50cc 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 heart mu
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 12,744
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 0296 01U and 0684 00 0296 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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