The National Consumer Commission (NCC) informs consumers and healthcare professionals of a product safety recall affecting certain Imager II Angiographic Catheters as notified by Boston Scientific. The recall affects 11 units sold nationally from 17 September 2025 to 04 May 2026. The product was distributed to Polokwane Provincial and Dr George Mukhari Hospitals.

According to the supplier, the recall is due to a manufacturing issue affecting the catheter tip. The most common adverse health consequence of tip detachment in the intravascular space, with a likelihood of occurrence every time used, is a delay in the procedure to exchange it for a new device. Although considered remote, the more serious potential adverse health consequence within the intravascular space is life-threatening embolism resulting from a device fragment obstructing blood flow, resulting in end-organ failure.

The Imager II Angiographic Catheter is a sterile, single-use intravascular catheter used for diagnostic angiography and for delivering Interlock-35 embolisation coils to specific sites in the peripheral vasculature. These catheters are available in a range of selective shapes and lengths and accept 0.035” (0.89mm) or 0.038” (0.97mm) guidewires. The catheter is radiopaque to allow visualisation during the procedure and has an atraumatic tip.

Healthcare professionals are advised to immediately discontinue use of the affected product and follow instructions as communicated to them by the supplier.

Consumers and healthcare professionals with questions or concerns relating to this recall may contact the NCC at ProductRecall@thencc.org.za.

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Issued by: National Consumer Commission (NCC) 

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