Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling Intra-Aortic Balloon Catheters 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 is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kits due to potential endotoxin contamination. The recall involves 69,278 kits with specific part numbers and lot numbers identified in the agency's records.
The affected products are indicated for use in acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure. The recall covers kits distributed worldwide, including the United States and numerous international markets.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice. Patients who have received these devices should contact their healthcare provider for guidance.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 69,278
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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