Official recall notice
FDA DeviceClass INotable
FDA Recall: DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H7871
- Recall date
- 2026-04-01
- Category
- Medical Device
- FDA class
- Class I
Why it was recalled
Hazard
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.
Recommended action
What to do
21,591
Product description
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, and procedure delay.