Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits 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 potential endotoxin contamination, a significant hazard, but the source text does not report any illnesses or injuries, meeting the criteria for a High severity score.
Plain-English summary
Datascope Corporation is recalling specific lots of Datascope Intra-Aortic Balloon Catheters (IABs)-Sensation 7Fr 34cc IAB Kits. The recall is being conducted due to potential endotoxin contamination in the product.
The affected product includes kits with part numbers 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, and 0684-00-0469-09. The source text lists numerous specific kit lot numbers associated with this recall. The product is indicated for use in acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.
The affected units were distributed worldwide, including the United States and numerous international markets. The source text does not specify the total number of units recalled or report any specific illnesses or injuries associated with the contamination. Healthcare providers and consumers should check their inventory for the listed part and lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of
- Manufacturer
- Datascope Corporation
- Hazard
- Affected units
- 13,335
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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