Z-1576-2026Class I

ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C...

Name: Z-1576-2026 ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C...
Creator: Merit Medical Systems, Inc.
Published: 2026-02-13
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2026-02-13 / Open, Classified / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C on 2026-02-13. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1576-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-02-13
Posted: 2026-03-26
Recalling firm: Merit Medical Systems, Inc.
Product: ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 2/13/2026, recall notices were mailed and emailed to customers who were asked to do the following: A picture of the 16F Dual-Valved Splittable Sheath Introducer is attached to help you identify the product. Place this notice and the picture on or near the affected product in your inventory (if applicable). Discontinue the use of the 16F Dual-Valved Splittable Sheath Introducer and destroy the sheath introducer at the point of use. Ensure that applicable personnel within your organization are made aware of this field action. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. Complete and return the customer response form via email to [email protected] If you have any questions concerning this communication, contact the firm's Customer Service via email at [email protected] or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri. On 4/2/2026, revised notices were mailed to customers that included stickers to be placed on affected devices to ensure awareness of the recall.
Quantity in commerce: 131
Distribution: Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV and OUS (International) to countries of : Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan
Product codes and lots: REF:UDI-DI/Lot(Expiration): DC01455550/C:00884450697870/H2600169; DC21452419/C:00884450697900/H2659228: DC21452419-NE5/C:00884450697894/H3249278): DC21452823/C:00884450697924/H2600164, H2628890; DC21452823-NE5/C:00884450697917/H2990807: DC21453227/C:00884450697948/H2630602; DC21454035/C:00884450697962/H2628887: DC21455550/C:00884450697979/H2630553, H2659229

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1576-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1575-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26
Z-1576-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26
Z-1577-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26
Z-1578-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26
Z-1579-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-04-01	2026-03-26

Product code MSD

K090148Class IIProguide Chronic Dialysis CatheterMerit Medical Systems, Inc. / cleared 2009-04-13

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)