Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling Intra-Aortic Balloon Catheters (IABs) due to potential endotoxin contamination. The affected kits were 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 potential endotoxin contamination, which poses a risk of harm (infection/sepsis) to patients. As no specific injuries or illnesses are reported in the source text, the hazard is theoretical, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters (IABs) MEGA 8Fr 50cc IAB Kits. The recall was initiated because of potential endotoxin contamination in the 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 31,529 units that were distributed worldwide, including the United States and numerous international markets.
Healthcare providers and facilities should identify any affected units by checking the lot numbers listed in the official recall notice. Patients who have received these devices should contact their healthcare provider for further instructions.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardi
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 31,529
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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