Z-1699-2021Class II

NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use

Name: Z-1699-2021 NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Creator: Marvao Medical Devices Ltd.
Published: 2020-02-11
License: https://open.fda.gov/license/

Marvao Medical Devices Ltd. / initiated 2020-02-11 / Open, Classified / root cause: labeling and UDI

FDA source

MARVAO MEDICAL DEVICES LTD. began a recall of NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use on 2020-02-11. FDA classified it as Class II and gives the reason as "The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1699-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-02-11
Posted: 2021-06-01
Recalling firm: Marvao Medical Devices Ltd.
Product: NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 02/10/2020, the firm emailed a "Direction For Use Update" Letter, to inform them that the firm has updated its Directions for Use (LS 122) from revision 01 to revision 02 and stated that the update is to provide clarification of an existing warning following a complaint where the stylet hub detached following removal without a guidewire in place. The updated DFU now includes the following statement, "The stylet is not to be removed without the guidewire in place. To remove the stylet forcibly in such cases could result in device damage". Customer are begin informed that the Recalling Firm will be removing LS 122 revision 01 which they currently have and replace it with LS 122 revision 02. This "rework" (replacement) will be conducted by the Recalling Firm's distributor DirectACCESS. The rework (replacement) will occur by the end of March 2020. A copy of the DFU is provided on the Recalling Firm's website and is also attached to the customer notification email. For questions associated with this correction - contact Recalling Firm at: Telephone number - +353 (0) 91 759 301 email - [email protected] or, DirectACCESS at (855)210-0554 Ext 114
Quantity in commerce: 292 devices
Distribution: U.S.: CO, NC, SC, TX, O.U.S.: Not provided
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1699-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1699-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-09	2021-06-01

Product code MSD

K173805Class IINexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)Marvao Medical Devices, Ltd. / cleared 2018-02-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)