Official recall notice
FDA DeviceClass INotable
FDA Recall: BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H
- 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
47,153
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.