Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling 3,542 Intra-Aortic Balloon Catheter kits worldwide due to potential endotoxin contamination.
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 with a potential contamination hazard (endotoxin) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Datascope Corporation is recalling 3,542 kits of Datascope Intra-Aortic Balloon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01. The recall is being conducted due to potential endotoxin contamination. The affected products are indicated for use in acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.
The affected kits were distributed worldwide, including in the United States and numerous international locations. The specific lot numbers affected are listed in the source documentation. No specific dates of distribution or illness reports are provided in the source text.
Healthcare providers and consumers should stop using the affected products immediately. Users should contact Datascope Corporation for further instructions regarding the return or replacement of the recalled kits.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - 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
- 3,542
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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