Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall covers 11,555 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 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), specifically the TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit. The recall is being conducted due to potential endotoxin contamination in the devices. The affected product is indicated for use in acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.
The recall involves 11,555 kits. These products were distributed worldwide, including nationwide in the United States and in numerous other countries such as 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. Specific lot numbers are listed in the official recall documentation.
Healthcare providers and patients should check their inventory and medical records for the specific lot numbers listed in the recall notice. If a patient has received one of these devices, they should contact their healthcare provider for further instructions. Datascope Corporation is the recalling firm responsible for this action.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - 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
- 11,555
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.
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