Boston Scientific Corporation: Expo 5F Angiographic Catheters Recalled for Potential Lining Detachment

What You Should Do

1. Identify if you have any affected Expo 5F Selective Angiographic Catheters by checking the Model/Reference (REF) numbers on the packaging, such as H74908526012, H74908526022, H74908526212, and H74908526222.
2. Carefully verify the Batch Numbers on the device labels against the extensive list of affected batches, which include thousands of specific codes such as 60425778, 60423767, 60427729, and 60427721.
3. Check for specific UDI/DI numbers on the product barcode, including 08714729187684, 08714729187691, 08714729187813, and 08714729187820 among others listed in the product details.
4. Immediately stop using any catheters from the identified affected batches and quarantine them to prevent further use in clinical settings.
5. Contact your healthcare provider if you are a patient who has recently undergone a procedure involving these catheters and have concerns.
6. Contact Boston Scientific Corporation directly at 1-888-463-6332 for specific instructions on returning the affected devices and to receive potential credits or replacements.
7. For additional questions or to report an adverse event, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products