Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP… — Class II medical device recall Z-2218-2024
Ongoing recall by Merit Medical Systems, Inc., reported 2024-07-03, distributed nationwide. Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tigh
| Recall number | Z-2218-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2024-05-22 |
| Classified | 2024-06-27 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CL, CO, CR, DO, EC, HK, KR, KY, MX, NZ, PE, UY, ZA |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00884450531709, 00884450531716, 00884450531730, 00884450531914, 00884450531921, 00884450531945, 00884450531952, 00884450531969, 00884450532065, 00884450532133, 00884450532140, 00884450532157, 00884450532164, 00884450532171, 00884450532300, 00884450532317, 00884450532324, 00884450532348, 00884450532515, 00884450532522, 00884450532539, 00884450532546, 00884450532553, 00884450532560, 00884450532577 and 9 more |
| Model numbers | PG4F45S, PG4F90S, PG5F45MP, PG5F45R, PG5F45S, PG5F45S018, PG5F90MP, PG5F90S, PG5F90S018, PG6F45HS, PG6F45MP, PG6F45R, PG6F45S, PG6F45S018, PG6F65MP, PG6F65S, PG6F65SX, PG6F90MP, PG6F90MPX, PG6F90SX, PG6F90SX018, PG7F45MP, PG7F45MPX, PG7F45RX, PG7F45S and 9 more |
Product
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP -PG7F45MPX -PG7F45RX -PG7F45S -PG7F45SX -PG7F65SX -PG7F90SX -PG8F45MPX -PG8F45S -PG8F45SX -PG8F65SX -PG8F90SX -X9PG700001 The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
Reason for recall
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
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-2218-2024. 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.