Merit Medical recalls certain DuraMax Chronic Hemodialysis Catheters due to a design defect that may cause bleeding, foreign bodies, or procedure delays. Affected units have specific serial 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 certain DuraMax Chronic Hemodialysis Catheters because a design flaw may prevent the sheath from splitting properly, leading to bleeding, foreign objects, or procedure delays. This could cause serious complications during dialysis treatments.
The catheter's sheath may not split as intended due to a design defect. This can cause bleeding, foreign bodies in the bloodstream, procedure delays, or blockages that impair dialysis function. In severe cases, it may lead to loss of the blood vessel for future treatments.
Patients using hemodialysis treatments with the recalled catheters are most at risk. Healthcare providers who use these catheters for dialysis procedures may also be affected.
Check the product's serial number on the packaging or label. The recalled catheters have specific reference numbers (H787103028015/A through H787103028235/A) and unique identifiers listed in the recall notice.
Look for the reference numbers (H787103028015/A through H787103028235/A) on the catheter's packaging or label to confirm if it is affected.
The catheter has a design defect that may prevent the sheath from splitting properly, which can cause bleeding, foreign bodies, procedure delays, or impaired function during dialysis.
Check the serial number against the list of affected units provided in the recall notice. If it is affected, contact Merit Medical Systems for further instructions.
Yes, the defect could cause bleeding, foreign bodies, or blockages that may lead to serious complications during dialysis treatments.
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-1578-2026 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1578-2026 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.
