BioFlo DuraMax® (REF H965103038041)Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
All models of BioFlo DuraMax (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450793831), received between Jul 29, 2025 and Mar 25, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Defective Device1
- Fracture1
- Infusion or Flow Problem1
- Material Deformation1
Patient problems
- Air Embolism1
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2026Fracture
A SEARCH IN THE ADVERSE EVENT NOTIFICATIONS (DAEN) DATABASE, REPORT NUMBER (B)(4), REPORTED THAT "A CRACK WAS NOTICED ON ONE OF THE LUMENS OF THE CATHETER AS IT LEAKED DURING FLUSHING AND AIR ASPIRATED WHEN THE CLAMPS WERE ON." NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Air Embolism
MAUDE report 24688208 ↗InjuryJul 29, 2025Break; Defective Device; Infusion or Flow Problem; Material Deformation; Break; Defective Device; Infusion or Flow Problem; Material Deformation
THE ACCOUNT ALLEGES A PATIENT CAME INTO THE EMERGENCY ROOM BECAUSE A CLAMP ON THE DIALYSIS CATHETER HAD BROKEN. A TEMPORARY CLAMP WAS PLACED IN BY THE EMERGENCY ROOM. THE PATIENT WAS THEN TRANSFERRED TO INTERVENTIONAL RADIOLOGY TO HAVE THE BROKEN CLAMP REPLACED. THE CATHETER WAS SUCCESSFULLY REPAIRED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22650589 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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