CentrosFLO Hemodialysis Catheters
Merit Medical recalls 80+ CentrosFLO hemodialysis catheter variants over sheath introducer splitting defect.
Stop using the affected catheters immediately. Contact Merit Medical Systems for instructions on returning the product and obtaining a replacement or refund.
Why it was recalled
Merit Medical Systems is recalling 80+ variants of CentrosFLO Hemodialysis Catheters due to a design defect in the 16F dual-valved splittable sheath introducer that may not split as intended, potentially causing hemorrhage, foreign bodies, procedure delay, embolization, impaired catheter function, or loss of vessel for future vascular access. The full list of affected REF codes is available on the FDA recall page.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C | 00884450697870, 00884450697900, 00884450697894, 00884450697924, 00884450697917, 00884450697948, 00884450697962, 00884450697979 | Z-1576-2026 |
| CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D | 00884450199992, 00884450725917, 00884450200001, 00884450200018, 00884450200025, 00884450200056, 00884450276068, 00884450820766, 00884450200063, 00884450276082, 00884450295526, 00884450820773, 00884450276105 | Z-1575-2026 |
| 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B | 00884450522196 | Z-1577-2026 |
| BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A | 00884450793206, 00884450793213, 00884450840733, 00884450786215, 00884450835326, 00884450786253, 00884450835333, 00884450793220, 00884450840740, 00884450793237, 00884450835340, 00884450793244, 00884450840757, 00884450793251, 00884450840764, 00884450792353, 00884450840771, 00884450793268, 00884450793282, 00884450793299 | Z-1579-2026 |
| DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A | 00884450794524, 00884450794548, 00884450786130, 00884450794555, 00884450786161, 00884450794562, 00884450794579, 00884450794586, 00884450794609, 00884450794623, 00884450794630, 00884450794647, 00884450794661, 00884450786178, 00884450794678, 00884450786185, 00884450794692, 00884450794708, 00884450794715, 00884450842249 | Z-1578-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Merit Medical Systems, Inc.
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification