Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects units 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 involves a medical device with a potential contamination hazard (endotoxin) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Datascope Corporation is recalling specific lots of Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kits. The recall is being conducted due to potential endotoxin contamination in the affected products.
The affected product is indicated for use in Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, and Complications of Heart Failure. The recall covers 16,104 units that were distributed worldwide, including the United States and numerous international markets.
Healthcare providers and facilities should check their inventory against the specific lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Datascope Corporation or the authorized distributor for further instructions.
The recalled product
- Product
- Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Car
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 16,104
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.
See all 17 products in this recall →Related recalls
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