Merit Medical recalls BioFlo DuraMax Catheters with specific serial numbers due to a design defect that may cause bleeding, foreign bodies, or procedure delays. Affected units include models H965103028011/A through H965103038181/A.
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 certain BioFlo DuraMax Catheters because a design defect may prevent the sheath from splitting properly, leading to bleeding, foreign bodies, or procedure delays. This could affect patients during medical procedures.
The catheter's dual-valved splittable sheath may not split as intended due to a design defect. This can cause bleeding, foreign bodies, procedure delays, embolization, or impaired catheter function during medical procedures.
Patients using the recalled catheters during medical procedures are most at risk. Healthcare providers who use these catheters for vascular access should check if their equipment is affected.
Check the product's serial number (REF) on the packaging or label. The affected models include H965103028011/A through H965103038181/A with specific expiration codes listed in the recall notice.
Look for the REF code on the catheter packaging or label to determine if it's affected.
Reach out to Merit Medical Systems for assistance with the recall and potential remedies.
The recall affects BioFlo DuraMax Catheters with REF codes H965103028011/A through H965103038181/A.
Check the product's serial number (REF) on the packaging or label. Affected models include H965103028011/A through H965103038181/A with specific expiration codes listed in the recall notice.
Contact Merit Medical Systems for assistance with the recall and potential remedies.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1579-2026 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-1579-2026 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.
