Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination
Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,275 kits distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this context, a serious contamination hazard in a critical medical device, align with a 'Severe' rating (Score 4), particularly given the potential for serious adverse health consequences from endotoxin exposure in an intra-aortic setting.
Plain-English summary
Datascope Corporation is recalling specific lots of Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 30cc IAB. The recall is being conducted because of potential endotoxin contamination in the affected products. The specific product part numbers involved are 0684-00-0294-01, 0684-00-0294-01U, 0684-00-0294-02, and 0684-00-0294-02U.
The recall covers 1,275 kits that were distributed worldwide, including nationwide distribution in the United States and various international markets. The source text lists specific kit lot numbers associated with this recall. These catheters are indicated for use in acute coronary syndrome, cardiac and non-cardiac surgery, and complications of heart failure.
Healthcare providers and facilities should check their inventory for the affected lot numbers and stop using these products immediately. Patients who have received these devices should contact their healthcare provider for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
- Manufacturer
- Datascope Corporation
- Hazard
- Affected units
- 1,275
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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