Recall of Prelude Roadster Guide Sheaths with specific model numbers due to risk of swivel nut detaching from HVA body if over-tightened during use.
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.
Merit Medical is recalling specific models of Prelude Roadster Guide Sheaths because older instructions may lead users to over-tighten the luer, potentially causing the swivel nut to detach from the HVA body. This could cause injury during medical procedures.
The recall is due to older version of the Instruction for Use (IFU) that instructs users to ensure the value and sheath are tightly connected before use. This may cause users to over-tighten the luer, which can result in the swivel nut detaching from the HVA body during medical procedures, potentially causing injury.
Medical professionals using the Prelude Roadster Guide Sheaths with the listed model numbers and lot codes. Patients undergoing procedures with these devices are at risk if the sheath detaches during use.
Check the model numbers listed in the recall (e.g., PG4F45S, PG5F45S) and lot numbers provided in the description. The sheaths are used for introducing interventional and diagnostic devices into blood vessels.
Identify the model number (e.g., PG4F45S) and lot number (e.g., H2409286) on the sheath's packaging or label.
If you have the recalled model or lot number, contact Merit Medical Systems for further instructions.
The recall includes model numbers starting with PG4F45S, PG4F90S, PG5F45MP, PG5F45R, PG5F45S, PG5F45S018, PG5F90MP, PG5F90S, and others as listed in the product description.
Check the model number and lot number on the sheath. The recall lists specific model numbers and corresponding lot numbers that were produced between certain dates.
Yes, the recall states that over-tightening the luer may cause the swivel nut to detach from the HVA body, which could lead to injury during medical procedures.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2218-2024 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-2218-2024 from Merit Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
