Health Canada Type II Recall 2026: Boston Scientific Direxion Microcatheters

Health Canada published a Type II health product recall on October 1, 2026, covering specific lots of Direxion and Direxion HI-FLO Microcatheters made by Boston Scientific Corporation. The recall is listed under identification number RA-82710 and carries a recall date of September 16, 2026. It is aimed at healthcare audiences who handle and use these medical devices.

According to the notice, Boston Scientific is initiating the removal of the affected lots because of a manufacturing issue. The problem may make it difficult to withdraw the device from its carrier hoop. It may also make it difficult to advance or withdraw the device through a guide catheter.

Recalled Products at a Glance

• Brand: Boston Scientific Corporation
• Products: Direxion and Direxion HI-FLO Microcatheters, including pre-loaded system versions
• Issue category: Medical devices – Performance
• Recall class: Type II
• Recall date: September 16, 2026
• Identification number: RA-82710
• Audience: Healthcare

Products Affected by This Recall

The notice lists several product families, each identified by model or catalogue number. Many entries state that more than ten lot or serial numbers are affected, and the notice directs readers to contact the manufacturer for those full lists.

The Direxion Hi-Flo Torqueable Microcatheter is listed under these model numbers: M001195400, M001195410, M001195420, M001195430, M001195440, M001195450, M001195470, M001195480, M001195500 and M001195510.

The Direxion Torqueable Microcatheter is listed under these model numbers: M001195200, M001195210, M001195220, M001195230, M001195240, M001195250, M001195260, M001195270, M001195280, M001195290, M001195300, M001195310, M001195320, M001195330, M001195340 and M001195350.

The pre-loaded system versions include the following:

• Direxion Hi-Flo Transend-18 System Pre-Loaded Torqueable Microcatheter: models M001195910 and M001195940, with more than ten lot numbers each
• Direxion Fathom-16 System Pre-Loaded Torqueable Microcatheter: models M001195610, M001195620, M001195640, M001195650, M001195660 and M001195670, with more than ten lot numbers each
• Direxion Transend-14 System Pre-Loaded Torqueable Microcatheter: models M001195810, M001195840 and M001195850
• Direxion Hi-Flo Fathom-16 System Pre-Loaded Torqueable Microcatheter: models M001195710, M001195720, M001195740 and M001195750

Lot Numbers Named in the Notice

For some models, the notice names the affected lots directly. Models M001195810, M001195840 and M001195850 of the Transend-14 system are linked to lots 37957749, 38181980, 38350332, 38629563, 38649510, 38687335, 39074451, 39187259 and 40512912.

Models M001195710, M001195720, M001195740 and M001195750 of the Hi-Flo Fathom-16 system are linked to lots 38273638, 38416365, 38445016 and 40485616.

What Triggered the Recall

Health Canada attributes the recall to a manufacturing issue affecting the performance of the devices. In practical terms, the notice describes two handling problems. The first is difficulty removing the microcatheter from the carrier hoop it ships in. The second is difficulty moving the device through a guide catheter, in either direction.

The notice classifies the issue as a performance problem and does not describe any injuries linked to it. Health Canada assigns Type II to recalls of products that may cause a temporary or medically reversible health problem, or where the risk of serious harm is considered remote.

Who Should Be Concerned

The recall is published for a healthcare audience, so the main readers are clinicians, hospitals and facilities that stock or use Direxion and Direxion HI-FLO Microcatheters in Canada. The notice categorizes the products under general hospital and personal use medical devices. Boston Scientific’s Canadian-facing listing names its address as 300 Boston Scientific Way, Marlborough, Massachusetts, United States.

Facilities should compare the model numbers and lot or serial numbers on the devices in their inventory against the entries in the official notice. Where the notice says more than ten numbers apply, the manufacturer is the source for the complete list.

What Consumers Need to Do Now

The guidance in the notice is brief: contact the manufacturer if you require additional information. Healthcare teams that hold any of the listed models should check their stock and confirm lot details with Boston Scientific before further use. The notice does not publish a toll-free number or email address, so facilities should use their existing Boston Scientific account or representative contacts.

Anyone who has a health or safety concern about a medical device can report it through the Government of Canada’s reporting page for health or safety concerns.

Regulatory Response

The recall was published by Health Canada under its Medical devices program and carries the identification number RA-82710. The notice was issued and last updated on October 1, 2026. Boston Scientific is described as initiating the removal of the specific lots, which indicates the action is manufacturer-led. Updates and related recall notices are available on the Government of Canada recalls and safety alerts site, where people can also subscribe to email notifications.