PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit… — Class II medical device recall Z-0949-2017
Terminated recall by Merit Medical Systems, Inc., reported 2017-01-11, distributed nationwide. Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips wer
| Recall number | Z-0949-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2016-12-01 |
| Classified | 2017-01-05 |
| Reported by FDA | 2017-01-11 |
| Terminated | 2017-04-18 |
| Distributed | Nationwide (US) |
| Quantity | 335 |
| Lot numbers | H1014678, H1029150, H1029151, H1039269, H1039272 |
Product
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires
Reason for recall
Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.
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-0949-2017. 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.