CLASS II ONGOING Device recall · Reported 9 Jun 2021 · FDA Enforcement Report
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use recalled
Marvao Medical Devices is recalling NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use, distributed in Colorado, North Carolina, South Carolina, Texas. The recall was initiated on 11 Feb 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1699-2021
- FDA event ID
- 87827
- Recalling firm
- Marvao Medical Devices, Galway
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Feb 2020
- FDA classified
- 1 Jun 2021
- Reported
- 9 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Feb 2020 | Recall initiated by company | |
| 1 Jun 2021 | Classified by FDA | +476 days |
| 9 Jun 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
Product as listed by the FDA
NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Where it was distributed
U.S.: CO, NC, SC, TX, O.U.S.: Not provided
Questions about this recall
Why was it recalled?
The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
Which lots are affected?
Model Number/Product Description/Lot Number: NEXHDSY1551901/NexSite HD Symmetric Tip Catheter 19cm/51377; NEXHDSY1552301/NexSite HD Symmetric Tip Catheter 23cm/51378; NEXHDSY1555501/NexSite HD Symmetric Tip Catheter 55cm/51380; NEXHDSY1552701/NexSite HD Symmetric Tip Catheter 27cm/51435;
Where was it sold?
U.S.: CO, NC, SC, TX, O.U.S.: Not provided
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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