Marva Medical recalls NexSite HD hemodialysis catheters for long-term use to ensure consistent instructions between field and website. Affected models include 19cm, 23cm, 55cm, and 27cm catheters with specific lot numbers.
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
Marva Medical is recalling NexSite HD hemodialysis catheters for long-term use because the instructions on the website don't match the actual field use. This mismatch could lead to incorrect use, but the recall doesn't involve immediate safety risks.
The hazard comes from inconsistent instructions between the product's field directions and the website. This mismatch might cause users to follow incorrect procedures, but it doesn't involve physical harm or immediate safety risks.
Hemodialysis patients using the NexSite HD catheters with model numbers NEXHDSY1551901, NEXHDSY1552301, NEXHDSY1555501, or NEXHDSY1552701 are most at risk. These catheters were sold with specific lot numbers for long-term use.
Check for model numbers NEXHDSY1551901 (19cm), NEXHDSY1552301 (23cm), NEXHDSY1555501 (55cm), or NEXHDSY1552701 (27cm) on the catheter packaging. These models were sold with specific lot numbers for long-term hemodialysis use.
Compare the product's field directions with the website instructions to ensure consistency.
No, the recall doesn't require stopping use. The issue is about instruction consistency, not safety risks.
Affected models include NexSite HD Symmetric Tip Catheters with model numbers NEXHDSY1551901 (19cm), NEXHDSY1552301 (23cm), NEXHDSY1555501 (55cm), and NEXHDSY1552701 (27cm).
The recall focuses on ensuring consistent instructions between field and website, but no specific fix or remedy is provided.
We’ve drafted a message you can send Marva Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1699-2021 — Marva Medical Marva Medical Hello, I own a Marva Medical that is covered by recall Z-1699-2021 from Marva 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.