FDA DeviceClass INotable

FDA Recall: BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H

Date: 2026-04-01
Brand: Merit Medical Systems, Inc.
Category: Medical Device
FDA Class: Class I

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.

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.

Remedy

47,153

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