DuraMax hemodialysis catheter sheath introducer may not split as intended
Merit Medical is recalling DuraMax Chronic Hemodialysis Catheters because a design defect in the 16F dual-valved splittable sheath introducer may prevent it splitting as intended.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
Merit Medical Systems, Inc. is recalling the DuraMax Chronic Hemodialysis Catheter across 21 REF numbers. About 21,591 units were distributed worldwide, covering 43 US states and more than fifty other countries.
The 16F dual-valved splittable sheath introducer, due to a design defect, may not split as intended. This may result in hemorrhage, foreign bodies, procedure delay, embolization or thrombosis, impaired catheter function, and loss of vessel for future vascular access. The FDA has classified this recall as Class I, its most serious category.
Affected product is listed by REF, UDI-DI and lot number in the FDA enforcement record.
Facilities can identify affected catheters by the REF and lot numbers, and may contact Merit Medical Systems, Inc. for further information.
The recalled product
- Product
- 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…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 21,591
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF:UDI-DI/Lot: H787103028015/A:00884450794524/I3049562
- H787103028025/A:00884450794531I3309371
- H787103028031/A:00884450794548/I2929299
- I3072553
- I3154760
- I3175731
- I3178921
- I3315957
- H787103028035/A:00884450786130/I2910259
- I2910261
- I2910262
- I2980545
- I2995795
- I3021388
- I3076851
- I3085062
- I3219446
- I3219454
- I3255314
- I3288649
Distribution
Part of a larger recall action
This product is one of 5 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Merit Medical Systems, Inc.
See all →- ModerateMerit Medical Systems Recalls Scout MD Delivery Systems Due to Deployment Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
Same hazard · design defect
See all →- HighUnited Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings
FDA (Devices) · 2026-08-12
- SevereMerit 16F splittable sheath introducer recalled as Class I bulk product
FDA (Devices) · 2026-04-01
- SevereProGuide chronic dialysis catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01
- SevereBioFlo DuraMax catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01
- SevereCentrosFLO hemodialysis catheters recalled as Class I over sheath introducer defect
FDA (Devices) · 2026-04-01
Similar recalls
- SevereArrow Edge hemodialysis kits contain a sheath introducer that may not split
FDA (Devices) · 2026-05-20
- HighMerit Medical Recalls Custom Sheath Introducer Kits Due to Labeling Error
FDA (Devices) · 2020-05-20
- SevereNextStep Hemodialysis Catheters with Defective Sheath Introducer
FDA (Devices) · 2026-05-20
- ModerateMerit Medical Prelude Pro Sheath Introducer Recalled for Incorrect Dilator Packaging
FDA (Devices) · 2015-07-01
- HighMerit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator
FDA (Devices) · 2021-08-18
- SevereCannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect
FDA (Devices) · 2026-05-20