ProGuide Chronic Dialysis Catheters — Class I medical device recall Z-1576-2026
Ongoing recall by Merit Medical Systems, Inc., reported 2026-04-01, distributed nationwide. 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may resu
| Recall number | Z-1576-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2026-02-13 |
| Classified | 2026-03-26 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BO, BR, BZ, CA, CH, CL, CO, CR, DE, DO, EC, ES, FR, GB, GR, GT, HK, HN, ID, IE, IQ, IR, IT, JO, JP, KY, LV, MX, MY, NI, NL, PA, PE, PL, QA, SA, SE, SK, SV, TH, VE, VN, ZA |
| Quantity | 131 |
| UPC / GTIN / UDI-DI | 00884450697870, 00884450697894, 00884450697900, 00884450697917, 00884450697924, 00884450697948, 00884450697962, 00884450697979 |
| Lot numbers | H2628890, H2659229 |
| Model numbers | DC01455550/C, DC21452419-NE5/C, DC21452419/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C, H2628890, H2659229 |
Product
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1576-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.