Imager II Angiographic Catheters Recalled Over Tip Defect: Health Canada

Health Canada has published a Type II health product recall notice for Boston Scientific’s Imager™ II Angiographic Catheters after the manufacturer identified a defect that could cause the catheter tip to break apart inside a patient’s blood vessel. The recall, dated August 24, 2026, and published on the Canada.ca recalls portal on September 4, 2026, carries the identification number RA-82589.

According to the notice, Boston Scientific determined that certain lots of the Catheters were manufactured with reduced levels of the stabilizing agents used in the tip material. This manufacturing shortfall raises the risk of tip degradation and, in more serious cases, detachment of the tip while the device is inside a patient during a diagnostic or interventional vascular procedure.

Why Was This Recall Issued?

The core issue is a materials problem at the catheter tip. Boston Scientific’s own testing found that the affected units did not contain the expected concentration of stabilizing agents, which are meant to keep the tip intact under the stresses of navigating a patient’s vasculature. Without adequate stabilization, the tip can weaken over the course of use, increasing the chance that a fragment separates and remains in the patient’s bloodstream.

Health Canada classified this as a Type II recall, a category generally reserved for situations where a product defect may cause temporary or medically reversible health consequences, or where the probability of serious harm is considered remote but not negligible.

Products Affected by This Recall

The removal covers several variants of the Imager II Catheter line, identified by distinct catalogue numbers and shape designations, including ‘Straight’, ‘Bern’, ‘H’, ‘RDC’, ‘C’, ‘SIM’, ‘MIK’, and ‘Contra 2’ configurations. Each variant is tied to specific catalogue numbers, such as M001314011, M001314031, M001314001, M001314021, M001314101, M001314081, M001314051, M001314061, M001314141, M001314151, M001314881, M001314621, M001314661, M001314671, M001314301, M001314321, M001314361, M001314341, M001314351, M001314771, M001314761, and M001314581.

Lot or serial numbers named in the notice include 74K2400624, 74G2500421, 74H2500875, 74A2600685, 74C2500767, 74M2500705, 74K2400620, 74G2500334, 74E2500884, 74G2500226, 74G2501346, 74C2500768, 74B2500492, 74M2500572, 74L2401251, 74L2500032, 74J2500080, 74K2400362, 74C2600733, 74G2500333, 74A2501314, 74D2500883, 74A2600684, 74C2600702, 74K2400616, 74G2500193, 74L2500029, and 74K2401117. For the ‘Bern’ and ‘C’ shaped catheters, Health Canada notes there are more than ten affected lot numbers and directs facilities to contact the manufacturer directly for the complete list.

Who Should Be Concerned

This is a healthcare-audience recall rather than a direct-to-consumer notice. The Catheters are used by hospitals, cardiac catheterization labs, and interventional radiology departments during angiographic procedures, where they help guide contrast media and instruments through a patient’s blood vessels. Boston Scientific Corporation, headquartered in Marlborough, Massachusetts, manufactures the devices, and the removal applies to affected stock distributed to Canadian healthcare facilities.

What Consumers Need to Do Now

Health Canada’s guidance for this notice is direct: facilities and clinicians who have received a customer letter regarding the affected devices should check their inventory against the lot and catalogue numbers listed above. Any matching units should be set aside and not used on patients pending further instruction from the manufacturer.

Because the notice is aimed at healthcare providers rather than patients purchasing the product themselves, individuals who have undergone a procedure involving an angiographic catheter and have concerns should speak with their treating physician or hospital rather than attempting to identify the device themselves. Facilities needing more information, including how to return or replace affected inventory, are directed to contact Boston Scientific directly.

From the Agency

Health Canada’s published notice states plainly that Boston Scientific is ‘initiating removal of Imager II Angiographic Catheters due to a manufacturing issue affecting the catheter tip,’ and that the reduced stabilizing agent levels ‘may increase the risk of tip degradation and detachment.’ The recall remains listed as an active Type II health product recall on the Canada.ca recalls and safety alerts database, with the agency continuing to direct affected parties to the manufacturer for further guidance.