FDA Device recall Z-1497-2017
7F Prelude¿ Short Sheath Introducer
- FDA Device
- Class I
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class I recall of 7F Prelude¿ Short Sheath Introducer by Merit Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1497-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-02-16 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot Numbers: H1041469, H1041473, H1036880, H1041464. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1497-2017%22
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