7F Prelude¿ Short Sheath Introducer — Class I medical device recall Z-1497-2017
Terminated recall by Merit Medical Systems, Inc., reported 2017-04-05, distributed nationwide. Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short
| Recall number | Z-1497-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2017-02-16 |
| Classified | 2017-03-24 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2017-08-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,265 total |
| Reason classes | device malfunction |
| Lot numbers | H1036880, H1041464, H1041469, H1041473 |
| Model numbers | K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT |
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 hemodialysis access.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1497-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.