OFFICIAL-SOURCE RECALL · AUSTRALIA
Imager II Angiographic Catheters Recall: Classification Class II Reason for the Action Boston
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Why this product was recalled
Classification Class II Reason for the Action Boston Scientific is initiating an urgent recall of Imager II Angiographic Catheters due to a manufacturing problem affecting the catheter tip. Boston Scientific has determined that these Catheters were manufactured with reduced levels of stabilising 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 recalled from the market. The most common adverse health consequence of tip detachment in the intravascular space is a delay in procedure to exchange for a new device. The most 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. Instructions for Customers/Users Customers are to: - Immediately stop further use or distribution and quarantine the
Hazard
Classification Class II Reason for the Action Boston Scientific is initiating an urgent recall of Imager II Angiographic Catheters due to a manufacturing problem affecting the catheter tip. Boston Scientific has determined that these Catheters were manufactured with reduced levels of stabilising 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 recalled from the market. The most common adverse health consequence of tip detachment in the intravascular space is a delay in procedure to exchange for a new device. The most 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. Instructions for Customers/Users Customers are to: - Immediately stop further use or distribution and quarantine the
Official recall notice
Imager II Angiographic Catheters
Agency: Therapeutic Goods Administration
Official publication date: October 8, 2026
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