Merit Medical recalls ProGuide Chronic Dialysis Catheters with design defect that may cause bleeding, blockage, or procedure delays. Affected models include DC01455550/C and others. Contact for remedy.
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 ProGuide Chronic Dialysis Catheters due to a design defect that may cause the catheter to fail to split properly. This can lead to bleeding, blockages, or complications during dialysis treatments. Patients using these catheters should stop using them immediately to avoid serious health risks.
The catheter's dual-valved splittable sheath may not split as intended due to a design flaw. This can cause bleeding, blockages, or complications like blood clots, which may lead to serious health issues during dialysis treatments.
Patients using ProGuide Chronic Dialysis Catheters with the listed model numbers are affected. Those with kidney failure requiring dialysis are most at risk.
Check the model number on the catheter packaging or label. Affected models include DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, and DC21455550/C.
Immediately stop using the recalled ProGuide Chronic Dialysis Catheters with the listed model numbers to prevent bleeding or blockages.
The catheter has a design defect that may cause it to fail to split properly, leading to bleeding, blockages, or complications during dialysis treatments.
Affected models include DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, and DC21455550/C.
Stop using the catheter immediately and contact Merit Medical Systems for further instructions.
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-1576-2026 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1576-2026 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.