The Recall Desk
Severity pendingFDA (Devices)·Z-1578-2026·Announced 2026-04-01

DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H7871

Pending LLM rewrite. Source: FDA_DEVICE Z-1578-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

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, H787103028181/A
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Devices

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

Distributed nationwide across the United States.

Related recalls

Same category