Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling 6,111 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 is classified as FDA Class II. The hazard involves potential endotoxin contamination in a medical device used for serious cardiac conditions, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Datascope Corporation is recalling 6,111 kits of Datascope Intra-Aortic Balloon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit, P/N: 0684-00-0559-01. The recall is being conducted due to potential endotoxin contamination in the devices.
The affected products were distributed worldwide, including the United States and numerous international markets. The specific lot numbers affected are listed in the structured product information provided by the agency.
Healthcare providers and facilities should stop using the affected lots and contact Datascope Corporation for further instructions on the recall process.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
- Manufacturer
- Datascope Corporation
- Hazard
- Affected units
- 6,111
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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