Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling 32,855 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products 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 high-risk medical device (invasive catheter) with a potential contamination hazard (endotoxin) that can cause serious harm, but the source text does not report specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Datascope Corporation is recalling 32,855 kits of Datascope Intra-Aortic Balloon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit. The recall is issued due to potential endotoxin contamination. The specific product numbers involved are 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, and 0684-00-0470-09.
These medical devices are indicated for use in acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure. The affected kits were distributed nationwide in the United States and internationally to numerous countries including Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Paraguay, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritius, Nigeria, Namibia, and Uganda.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to Datascope Corporation or the authorized distributor for credit or replacement.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - 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
- 32,855
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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