Back to RecallTracker
Health Canada Medical devices

Prelude Roadster Guide Sheath

Issued April 8, 2024
Issue
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
Hazard description
Labelling and packaging
Product
Product name
Prelude Roadster Guide Sheath
Reference
ID
RA-75360