Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling 3,055 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 with a potential contamination hazard (endotoxin) where no specific injuries or illnesses have been 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 3,055 kits of Datascope Intra-Aortic Balloon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan). The recall was initiated due to potential endotoxin contamination in the product.
The affected kits are identified by specific lot numbers listed in the recall documentation. These medical devices are indicated for use in acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.
The products were distributed worldwide, including the United States and numerous international markets. Healthcare providers and patients should contact Datascope Corporation for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - 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
- 3,055
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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