Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope is recalling specific 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 is classified as FDA Class II, and the hazard involves potential endotoxin contamination in a medical device, which poses a risk of harm even if specific injury reports are not detailed in the provided text.
Plain-English summary
Datascope Corporation is recalling 3,059 kits of Trans-Ray 7Fr 40cc Intra-Aortic Balloon Catheters (IABs). The recall is issued due to potential endotoxin contamination in the devices. These medical devices are indicated for use in acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.
The affected product is identified by Kit P/N 0684-00-0546-01. The recall covers specific lot numbers, including 3000051381, 3000053316, and 3000057969, among others. The devices were distributed worldwide, including in the United States and numerous international markets such as Canada, the United Kingdom, and Japan.
Healthcare providers and facilities should stop using the affected lots immediately. Users should check their inventory against the provided lot numbers and contact Datascope Corporation for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01
- Manufacturer
- Datascope Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 3,059
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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