Boston Scientific recalls catheters distributed at SA public hospitals

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According to the National Consumer Commission (NCC), the recall affects 11 units sold nationally from 17 September 2025 to 4 May 2026.

The NCC has advised healthcare professionals to stop using the affected product immediately and follow the supplier’s instructions.

Procedure delay

A statement from the NCC indicates that the recall is due to a manufacturing issue affecting the catheter tip.

The most common adverse effect of tip detachment in the intravascular space is a procedure delay while the device is replaced.

Although considered remote, a more serious potential adverse effect in the intravascular space is a life-threatening embolism, caused by a device fragment obstructing blood flow and resulting in end-organ failure.

Recall notice: Boston Scientific recalls medical devices over safety concerns

14 Apr 2026

The Imager II Angiographic Catheter is a sterile, single-use intravascular catheter used for diagnostic angiography and to deliver Interlock-35 embolisation coils to specific sites in the peripheral vasculature.

These catheters come in selective shapes and lengths and accept 0.89mm or 0.97mm guidewires.

The catheter is radiopaque for visualisation during the procedure and has an atraumatic tip.

The commission encourages consumers and healthcare professionals with questions or concerns about this recall to contact the NCC at az.gro.ccneht@llaceRtcudorP.