The U.S. Food and Drug Administration (FDA) has announced a Class I recall of Boston Scientific's IMAGER II 5F Angiographic Catheters due to "a potential for the catheter tip to become detached during a patient procedure or during procedure preparation."

Additional surgical intervention to remove the catheter tip in the patient's blood vessel and increased time in the hospital may be needed with continued use of the product. Serious adverse events, such as obstruction of blood flow (embolism), stroke, or death, may also potentially occur.

Nine injuries have been reported to date. For more instructions on reporting and product return, and for a full list of affected devices, read the full FDA recall.

Keywords: ACC Advocacy, United States Food and Drug Administration, Catheters, Embolism, Stroke

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