Abbott Vascular Issues Worldwide Recall of Coronary Catheters for Balloon Problems
Abbot Vascular has issued a worldwide recall on three of its coronary catheters:
- NC Trek RX Coronary Dilatation Catheter
- NC Traveler RX Coronary Dilatation Catheter
- NC Tenku RX PTCA Balloon Catheter
Almost half a million lots have been recalled because of difficulties associated with removing the protective balloon sheath. As a result, the Food & Drug Administration has issued a Class I recall – its most serious category. If the balloon sheath is damaged while users attempt to remove it, the device could fail to inflate or deflate properly, which could lead to the death of the patient. Other potential complications include:
- Air embolism
- Thrombosis
- Myocardial infarction
- Necessary revision surgery
Here is a complete list of the recalled lots.
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