Imager™ II Angiographic Catheter

Brief description of the problem (reason for recall)

Boston Scientific is initiating a recall of Imager™ II Angiographic Catheters (“Catheters”) due to a manufacturing issue affecting the catheter tip. This recall affects the devices identified in Attachment 1. Boston Scientific has determined that these Catheters were manufactured with reduced levels of stabilizing agents in the tips. This may increase the risk of tip degradation and detachment. Although no increase in tip detachment complaints has been identified for the affected lots, the devices were manufactured outside the approved design specification and are being removed from the market. In addition, as previously communicated, Boston Scientific has made the decision to discontinue selling this product.

Advice for health professionals and distributors:

Please immediately discontinue use of the Boston Scientific product reported in the list (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 on or before 11 Sept 2026.

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).

Your National Competent Authority has been informed of this communication. Any adverse events or quality concerns associated with use of these devices should be reported to Boston Scientific and where required, to the applicable Competent Authority.

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.

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.