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Early Alert: Angiographic Catheter Issue from Boston Scientific
The FDA is aware that Boston Scientific has issued a letter to affected customers recommending all Imager II Angiographic Catheters be removed from where they are used or sold. This recall is due to a manufacturing issue affecting the catheter tip.
Boston Scientific has determined that these catheters were manufactured with reduced levels of stabilizing agents in the tips. This may increase the risk of tip degradation and detachment.
Although no increase in tip detachment complaints has been identified for the affected lots, the devices were manufactured outside the approved design specification and are being removed from the market. In addition, Boston Scientific has made the decision to discontinue selling this product.
The most common adverse health consequence of tip detachment in the intravascular space with a likelihood of occurrence of every time used is a delay in procedure to exchange for a new device. Although considered remote, the most serious potential adverse health consequence within the intravascular space is life threatening embolism resulting from a device fragment obstructing blood flow resulting in end organ failure.
As of July 16, Boston Scientific has reported two serious injuries and no deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Boston Scientific at BSCComplaints@bsci.com.
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