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Serious riskFDA DeviceClass I

Merit Medical ProGuide sheath introducers recalled for design defect

Merit Medical Systems is recalling certain ProGuide Chronic Dialysis Catheters with a 16F dual-valved splittable sheath introducer due to a design defect. The sheath may not split as intended during insertion, which could cause serious complications including bleeding, blood clots, or damage to blood vessels.

From the FDA notice · Read the official notice ↗ · All Merit Medical recalls

What to do

  1. Stop using affected catheters immediately if you have one with the recalled reference numbers (DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C)
  2. Contact your dialysis center or healthcare provider right away to discuss your catheter and get a replacement
  3. Check the lot number on your catheter packaging against the FDA recall list
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 5 products — see all of them.

Details

Units affected
131
Illnesses reported
None reported
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Classification
Class I
Recall number
Z-1576-2026

In the FDA's words

Description
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C 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. 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 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 Affected quantity: 131
Hazard
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.

5 products in this recall

Merit Medical catheters, sheath introducers recalled for splitting defect

Merit Medical is recalling five products, including CentrosFLO and DuraMax dialysis catheters and 16F dual valved splittable sheath introducers. The sheath introducer may not split as intended, which can cause bleeding, pieces left in the body, procedure delays, or blood clots. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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