The proximal marker on devices from these lots may separate from the device. A dislodged marker may require additional intervention, including unplanned additional coronary intervention, or surgery. To date Abbott has received 5 complaints related to this issue, one which resulted in an embolism which required an additional intervention to resolve with no immediate adverse consequences. Potential risks include embolism, cardiovascular injury and myocardial ischemia. Recall start date: Apr 11, 2022
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