Class I — Merit Medical Systems, Inc.
| Recalling firm | Merit Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude® Short Sheath Introducers because the sheath marker tips may detach during use. |
| Product | 7F Prelude® Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude® Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or he… |
| Quantity | 1,265 total |
| Distribution | Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees. |
| Initiated | 2017-02-16 |
| Classified | 2017-03-24 |
| Terminated | 2017-08-08 |
| Recall number | Z-1497-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Merit Medical Systems, Inc. (Z-1497-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76596/
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