Health Canada Recalls Abbott Amplatzer Amulet Occluder Over Label Update

Health Canada has classified a Type II recall for the Amplatzer™ Amulet™ Left Atrial Appendage Occluder, a cardiac implant manufactured by Abbott Medical, after the company updated the device’s instructions for use to add new warnings about a risk known as pulmonary artery injury. The recall, identified under reference number RA-82682, was dated 2026-09-10 and published by Health Canada on 2026-09-25.

Unlike many device recalls, this action does not involve a physical defect or malfunction. Health Canada states explicitly that the recall is not associated with defectiveness or possible defectiveness. Instead, Abbott is notifying hospitals and healthcare providers who use the device about revised labelling language intended to help doctors avoid a rare but serious complication during implantation.

What Products Are Being Recalled?

The action covers the Amplatzer™ Amulet™ Left Atrial Appendage Occluder across several model and catalogue numbers, including 9-ACP2-010-028, 9-ACP2-010-031, 9-ACP2-010-034, 9-ACP2-007-020, 9-ACP2-007-022, 9-ACP2-007-016, 9-ACP2-007-018 and 9-ACP2-010-025. According to the manufacturer, more than ten lot or serial numbers are affected for each listed model, and healthcare facilities are being told to contact Abbott Medical directly for the complete list of affected units.

The device itself is used to close off the left atrial appendage of the heart, a procedure typically performed to reduce stroke risk in certain patients with atrial fibrillation who cannot tolerate long-term blood thinners.

Why Was This Recall Issued?

The current instructions for use already warn against placing the device where it would interfere with any intracardiac or intravascular structures. Abbott is now updating that contraindication to specifically name the pulmonary artery as one of the structures that must be considered during placement.

The revised labelling also adds guidance for physicians on how to assess the distance between the intended device landing zone and the pulmonary artery before implantation. Abbott has reportedly completed additional physician training related to this issue. The underlying concern is pulmonary artery injury, or PAI, a rare complication that can occur if the occluder is positioned too close to the artery during the procedure.

Who Should Be Concerned?

This recall is directed at healthcare professionals and institutions rather than individual patients. Health Canada lists the intended audience as healthcare providers, meaning hospitals, cardiac catheterization labs and implanting physicians who stock or use the Amulet™ device are the primary parties expected to act on the updated information.

Patients who have already received the implant are not being asked to take any direct action as a result of this notice, since the recall concerns future procedural guidance rather than devices already implanted.

What Should Healthcare Providers Do?

Consignees and facilities that use the Amplatzer™ Amulet™ device are advised to review the updated instructions for use and incorporate the new pulmonary artery guidance into procedural planning. Anyone needing further clarification or the full list of affected lot numbers should contact Abbott Medical directly.

• Review the revised contraindication language regarding intracardiac and intravascular structures.
• Apply the new guidance on measuring the distance between the landing zone and the pulmonary artery.
• Confirm whether facility stock includes any of the listed model numbers.
• Contact Abbott Medical for specific lot or serial number details.
• Direct any additional questions to Health Canada’s medical device recall line.

Regulatory Response

Health Canada has categorized the action as a Type II recall under the health products classification for medical devices, specifically cardiovascular devices. The recall was published under the identification number RA-82682, with an issue category described as labelling and packaging. Abbott Medical, based in Plymouth, Minnesota, is listed as the responsible company.

Health Canada continues to monitor medical device safety communications and encourages healthcare providers to report any device-related concerns through its official reporting channels.