Boston Scientific Recalls Angiographic Catheters Distributed to Two SA Hospitals
Boston Scientific Recalls Angiographic Catheters Distributed to Two SA Hospitals. Medical technology company Boston Scientific has recalled its Imager II Angiographic Catheters after a manufacturing issue affecting the catheter tip was identified.
According to the National Consumer Commission (NCC), the recall affects 11 units sold nationally between 17 September 2025 and 4 May 2026. The affected products were distributed to Polokwane Provincial Hospital and Dr George Mukhari Hospital.
The NCC has advised healthcare professionals to immediately stop using the affected catheters and follow the instructions provided by the supplier.
The recall relates to a manufacturing issue that could result in detachment of the catheter tip. According to the NCC, the most common adverse effect if a tip detaches in the intravascular space is a delay to the procedure while the device is replaced.
The commission said a more serious, although remote, potential adverse effect is a life-threatening embolism. This could occur if a detached device fragment obstructs blood flow and results in end-organ failure.
The Imager II Angiographic Catheter is a sterile, single-use intravascular catheter used during diagnostic angiography and to deliver Interlock-35 embolisation coils to specific sites in the peripheral vasculature.
The catheters are available in different selective shapes and lengths and are designed to accept 0.89mm or 0.97mm guidewires. They are also radiopaque, allowing them to be visualised during procedures, and feature an atraumatic tip.
The NCC has urged healthcare professionals using the affected products to follow the supplier’s recall instructions.
