BioFlo DuraMax® (REF H965103028031)Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450786215), received between Apr 25, 2025 and Mar 25, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Defective Device” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Feb 13, 2026Open, Classified
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.
Z-1579-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Defective Device3
- Product Quality Problem3
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2026Separation Problem
THE CUSTOMER REPORTS THAT THE PEELABLE INTRODUCER OF THE DURAMAX BIOFLO DOES NOT PEEL EVENLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688214 ↗MalfunctionApr 25, 2025Product Quality Problem; Defective Device; Product Quality Problem; Defective Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21913143 ↗MalfunctionApr 25, 2025Product Quality Problem; Defective Device; Product Quality Problem; Defective Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21913117 ↗MalfunctionApr 25, 2025Product Quality Problem; Defective Device; Product Quality Problem; Defective Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21913116 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.