Official recall record

Prelude Roadster Guide Sheath

Health Canada — Medical Devices · 2024-04-08 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2024-04-08
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

Merit Medical Systems, Inc. is voluntarily conducting a recall of the Prelude Roadster Guide Sheath due to an incorrect dilator included with the product. This is limited to sheaths labeled with .018" dilators, which may contain .038" dilators. This affects two lots. Merit has not received any reports of patient harm or injury relating to this issue; however, Merit has received one complaint relating to this issue. Use of the incorrect dilator may result in procedure delay or soft tissue injury. Recall Start Date: March 14, 2024

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 2026-05-31.

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