Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications
Datascope is recalling 655 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, but the source text identifies the issue as a missing documentation section (Contraindications) without reporting any injuries, illnesses, or specific high-risk contamination, fitting the criteria for a moderate severity labeling/documentation error.
Plain-English summary
Datascope Corporation is recalling 655 units of the Mega Intra-Aortic Balloon Catheter (7.5FR 30cc). The recall was initiated because the U.S. Instructions For Use for the device were missing the Contraindications section.
The affected products were distributed nationwide in the United States. The specific product codes involved are 0684 00 0294 01U and 0684 00 0294 02U. The intra-aortic balloon catheter is used to provide counterpulsation therapy in the aorta to increase blood supply to the heart muscle.
Healthcare providers and facilities should stop using the affected devices and contact Datascope Corporation for further instructions on the recall.
The recalled product
- Product
- Intra-Aortic Balloon Catheter Mega 7.5FR 30cc 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
- Affected units
- 655
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 0294 01U and 0684 00 0294 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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