FDA Device recall Z-2218-2024
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F…
- FDA Device
- Class II
- ongoing
- Published 2024-07-03
On 2024-07-03 the FDA classified a Class II recall of Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F… by Merit Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2218-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-22 |
| Published | 2024-07-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog Code/Lot Number/UDI-DI PG4F45S H2409286 00884450531709 H2511381 00884450531709 H2532402 00884450531709 H254273…Catalog Code/Lot Number/UDI-DI PG4F45S H2409286 00884450531709 H2511381 00884450531709 H2532402 00884450531709 H2542733 00884450531709 H2602038 00884450531709 H2613452 00884450531709 H2655892 00884450531709 H2668983 00884450531709 H2684566 00884450531709 H2800559 00884450531709 H2808568 00884450531709 H2817152 00884450531709 H2830841 00884450531709 H2839229 00884450531709 H2852688 00884450531709 PG4F90S H2418703 00884450531716 H2478781 00884450531716 H2532524 00884450531716 H2542736 00884450531716 H2642436 00884450531716 H2662245 00884450531716 H2668984 00884450531716 H2684572 00884450531716 H2757247 00884450531716 H2763317 00884450531716 H2876572 00884450531716 PG5F45MP H2409290 00884450531914 H2478782 00884450531914 H2542737 00884450531914 H2633727 00884450531914 H2655894 00884450531914 H2662249 00884450531914 H2684571 00884450531914 H2722066 00884450531914 H2757249 00884450531914 H2777503 00884450531914 H2785759 00884450531914 H2821571 00884450531914 H2830842 00884450531914 PG5F |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2218-2024%22
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