Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,746 kits distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk pathogen (endotoxin) in a medical device, but no illnesses or injuries have been reported in the source text.
Plain-English summary
Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters (IABs) Linear 7.5Fr 25cc IAB Kits. The recall is being conducted due to potential endotoxin contamination in the devices. The affected product is used for indications including Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, and Complications of Heart Failure.
The recall involves 1,746 kits that were distributed worldwide, including nationwide distribution in the United States and in numerous other countries. Specific lot numbers are listed in the official recall documentation. The agency has classified this as a Class II recall.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using the devices. Patients who have received these devices should contact their healthcare provider for guidance. The recall is voluntary and precautionary.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 1,746
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 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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