Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling 2,550 kits of Trans-Ray 7Fr 34cc Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected devices 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 is classified as FDA Class II, and the hazard involves potential endotoxin contamination in a medical device used for serious cardiac conditions. No specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Datascope Corporation is recalling 2,550 kits of Trans-Ray 7Fr 34cc Intra-Aortic Balloon Catheters (IABs) (Japan) Kit, Product Number 0684-00-0545-01. The recall is being conducted due to potential endotoxin contamination. The affected devices are indicated for use in acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.
The recall covers specific lot numbers including 3000066986, 3000069732, 3000077731, 3000077732, 3000080305, 3000083332, 3000083333, 3000084968, 3000087492, 3000095469, 3000096180, 3000096181, 3000096585, 3000098052, 3000103498, 3000104616, 3000104617, 3000112275, and 3000113067. The source text does not specify the dates of manufacture or distribution for these lots.
The affected products were distributed worldwide, including nationwide distribution 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. Healthcare providers and facilities should check their inventory for these specific lot numbers and contact Datascope Corporation for further instructions.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
- Manufacturer
- Datascope Corporation
- Hazard
- Affected units
- 2,550
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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