Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 29,653 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 the hazard involves potential endotoxin contamination, which is a significant risk-of-harm factor for medical devices where injury has not yet been reported.
Plain-English summary
Datascope Corporation is recalling specific lots of Datascope Intra-Aortic Balloon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kits due to potential endotoxin contamination. The affected product is used for indications including acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.
The recall involves 29,653 kits distributed worldwide, including in the United States and numerous international markets. The specific lot numbers affected are: 3000102215, 3000102248, 3000102249, 3000103405, 3000103406, 3000105261, 3000105262, 3000106963, 3000107331, 3000107332, 3000108589, 3000108881, 3000110520, 3000111682, 3000113810, 3000046748, 3000102329, and 3000103404.
Healthcare providers and patients should check their inventory and patient records for these specific lot numbers. If the product is found, it should be removed from use and returned to Datascope Corporation or the distributor for credit or replacement.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failu
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 29,653
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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