Merit Medical recalls AccessPLUS Large Bore Hemostasis Valves with a design gap that may cause guidewire delays during procedures. Affected models include catalog codes 580758001, 580774001, and others. No remedy specified in recall notice.
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device. This defect may result in a delay of procedure.
Merit Medical is recalling certain AccessPLUS Large Bore Hemostasis Valves due to a design flaw that creates an internal gap where guidewires can get stuck, potentially delaying medical procedures. This issue affects specific model numbers and lots, but the recall does not include a fix or return process.
A design change to improve manufacturing created a gap between the rotator and Y-body of the valve. This gap can trap guidewires, making it difficult to advance them through the device during medical procedures, which may delay critical treatments.
Healthcare professionals using these hemostasis valves during medical procedures are most at risk. Patients receiving procedures with the recalled valves may experience delays.
Check for the catalog codes listed in the recall notice: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, and other model numbers with specific lots or serial numbers.
Review the catalog codes and lots listed in the recall notice to confirm if your valve is affected.
The recall notice does not specify any remedy or action steps for affected valves.
The recall applies to hemostasis valves used during procedures where guidewires are advanced through the device, such as certain vascular or surgical interventions.
Check the catalog codes and specific lots listed in the recall notice, including model numbers like 580758001, 580774001, and others with associated serial numbers.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0904-2022 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0904-2022 from Merit Medical. 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.
