Direxion™ and Direxion HI-FLO™Microcatheters

Brief description of the problem (reason for recall)

Boston Scientific is initiating the recall of specific lots of Direxion™ and Direxion HI-FLO™ Microcatheters due to a manufacturing issue that may cause difficulty withdrawing the device from the carrier hoop and difficulty advancing or withdrawing the device through a guide catheter. This recall affects only the lots identified in Attachment 1. The issue is detectable during device preparation and/or use in the patient and is experienced as increased resistance between the microcatheter and other components. This increased resistance, including attempts to advance or withdraw the device when resistance is encountered, may result in damage to the microcatheter. Potential adverse health consequences include prolonged procedure, vessel trauma, vasospasm, additional intervention to retrieve a separated device fragment, unretrieved device fragment, thrombosis, or embolism.

Advice for health professionals and distributors:

Boston Scientific requests that you read this notice carefully and complete the following actions.

• Please immediately discontinue use of the Boston Scientific product reported in the list below (Attachment 1) and remove all of the affected units from your inventory, regardless of where these units are stored in your facility. Segregate the units in a secure place, pending return to Boston Scientific.
• Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device.
• Continue to follow the standard of care when monitoring patients treated with the product.
• Please complete the attached Verification Form even if you do not have any product to return.
• When completed, please return the Verification Form to your local Boston Scientific office for the attention of promptly upon receipt and no later than 10 working days from receipt of this notification.
• If you have products to return, please package them in an appropriate shipping box. After receipt of the Verification Form, Boston Scientific will contact you to arrange return.
• Please pass this notice to any health professional from your organization that needs to be aware and to any organization where the potentially affected devices have been transferred (if appropriate). Please provide Boston Scientific with details of any affected devices that have been transferred to other organizations (if appropriate).
• Patient safety is Boston Scientific’s highest priority. As such, we are committed to transparent communication with physicians and healthcare professionals to ensure you have timely, relevant information for managing your patients. If you have any questions or would like assistance with this Field Safety Notice, please contact your local Sales Representative at KgahlishoKay.Madisha@bsci.com.

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points, and the recall process was initiated.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.