Merit Medical recalls Access-9 Large Bore Hemostasis Valves with a design gap that may cause guidewire delays during procedures. Affected models include specific catalog codes and lots.
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 Access-9 Large Bore Hemostasis Valves due to a design change that created an internal gap. This gap can cause guidewires to get stuck, delaying medical procedures. The issue affects specific model numbers and production lots.
A design change to improve manufacturing created a small 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 surgery.
Healthcare professionals using the Access-9 valves for procedures are most at risk. Patients receiving these valves during surgery may experience delays in treatment.
Check for the catalog code 580775001, model numbers like IN8112/C, K05-00053H, or lots listed in the detailed codes and production numbers provided in the recall notice.
Review the catalog code, model numbers, and production lots listed in the recall notice to confirm if your device is affected.
A design change made to improve manufacturability created an internal gap that can trap guidewires, potentially delaying procedures.
Check for the catalog code 580775001, model numbers like IN8112/C, K05-00053H, or specific production lots listed in the recall notice.
The recall notice does not specify a remedy, so contact Merit Medical directly for guidance on next steps.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0903-2022 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-0903-2022 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.
