Devices

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications.

The agency announced the Class I classification 9/25, updating an Early Alert it issued 8/28. Boston Scientific previously instructed customers to remove all affected Imager II Angiographic Catheters from use and distribution.

As of July 16, the company had reported two serious injuries and no deaths associated with the issue.

The recall stems from reduced levels of stabilizing agents in the catheter tips, which may increase the risk that a tip will degrade and detach during use. FDA said Boston Scientific determined that the affected devices were manufactured outside approved design specifications.

Although the company has not identified an increase in tip-detachment complaints among the affected lots, it is removing the products from the market and has decided to discontinue the Imager II catheter line.

FDA said the most common consequence of a catheter-tip detachment in the intravascular space would be a procedural delay while the device is replaced. The most serious potential consequence, although considered remote, is a life-threatening embolism caused by a device fragment obstructing blood flow and potentially resulting in end-organ failure.

The Imager II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters available in various shapes and lengths. They are used to create images of specific areas of the peripheral vasculature.

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