A recall has been issued for Imager II 5F catheters due to potential adverse reactions including death.
About the Class 1 Catheter Recalls
Boston Scientific is a corporation that manufactures medical aids and technology. Recently, they were forced to voluntarily recall their Imager II 5f angiographic catheters due to critical defects. According to Medscape, a portion of the catheters had the potential to break off within a patient’s blood stream or vessels. These occurrences were most likely to happen during important procedures such as surgery.
The Food and Drug Administration (FDA) quickly issued the catheters as a Class 1 recall with a total report of 9 injuries so far. A Class 1 recall is acknowledged for its high probability of causing adverse medical problems including death and should be taken seriously.
A summary of the recall notice from the FDA warned that the catheters could possibly attribute to prolonged time periods within a hospital due to emergency surgeries needed to remove the catheter. They also noted that more serious problems could occur such as strokes or even death from usage.
Boston Scientific has been desperately working to notify all affected medical facilities using their catheters to send them back to their company.
Description of the Recalled Boston Scientific Catheters
- 6130 single units (1226 five-packs) were recalled
- The Imager II 5F angiographic catheters were distributed throughout the United States from July 16, 2018- November 26, 2019
- Contact information: BSCFieldActionCenter@bsci.com
Contact an Experienced Defective Medical Device Attorney
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