Official recall record
Direxion and Direxion HI-FLO Microcatheters
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-10-01
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Boston scientific is initiating the removal of specific lots of Direxion and Direxion HI-FLO Microcatheters due to a manufacturing issue that may cause difficulty withdrawing the device from the carrier hoop and difficulty advancing or withdrawing the device through a guide catheter.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-10-12.
Record last checked against the registry on 2026-10-12.
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