Merit Medical recalls 16F Dual Valved Splittable Sheath Introducers (non-sterile) due to a design defect that may cause bleeding, foreign bodies, or procedure delays. Affected units have specific reference numbers.
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Merit Medical is recalling 16F Dual Valved Splittable Sheath Introducers (non-sterile) because a design defect may cause them to not split as intended. This could lead to bleeding, foreign objects, procedure delays, or complications during medical procedures.
The device has a design flaw that prevents it from splitting properly during medical procedures. If it doesn't split as intended, it can cause bleeding, leave foreign objects inside the body, delay procedures, or lead to blood clots or vessel damage.
Healthcare professionals using this specific medical device for procedures are likely affected. Patients undergoing procedures with this device may be at risk if the device fails to split correctly.
Check for the reference number FCL-174-00/B on the product label. This device is sold in bulk, non-sterile form and has specific serial numbers listed in the recall notice.
Look for the reference number FCL-174-00/B on the device label to confirm if it's affected.
The recall states the device has a design defect that may cause it to not split as intended, which could lead to bleeding or other complications. It is not safe to use without checking the recall status.
Check the product label for the reference number FCL-174-00/B. If it matches, contact Merit Medical for instructions on what to do next.
Yes, if the device fails to split correctly during a procedure, it could cause bleeding, foreign objects in the body, or complications like blood clots or vessel damage.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1577-2026 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1577-2026 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.
