ProGuide Chronic Dialysis Catheters recall
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Why was ProGuide Chronic Dialysis Catheters recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 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
- Recall date
- April 1, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)