DuraFlow 2Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450786116), received between Mar 19, 2026 and Mar 30, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Obstruction of Flow” (3 reports).
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
- Obstruction of Flow3
- Expulsion1
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.
InjuryMar 30, 2026Obstruction of Flow
CUSTOMER REPORTS PLACEMENT WENT WELL, BUT A COUPLE DAYS LATER WHEN THE PATIENT WENT FOR DIALYSIS, THEY NOTICED THE CATHETER WAS CLOGGED. THE PATIENT WAS BROUGHT BACK TO HAVE THE CATHETER REPLACED ON (B)(6) 2024. THERE WAS NO INJURY TO THE PATIENT. NO ADDITIONAL DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24724666 ↗InjuryMar 30, 2026Obstruction of Flow
CUSTOMER REPORTS PLACEMENT WENT WELL, BUT A COUPLE DAYS LATER WHEN THE PATIENT WENT FOR DIALYSIS, THEY NOTICED THE CATHETER WAS CLOGGED. THE PATIENT WAS BROUGHT BACK TO HAVE THE CATHETER REPLACED ON (B)(6) 2024. THERE WAS NO INJURY TO THE PATIENT. NO ADDITIONAL DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24723910 ↗InjuryMar 30, 2026Obstruction of Flow
CUSTOMER REPORTS PLACEMENT WENT WELL, BUT A COUPLE DAYS LATER WHEN THE PATIENT WENT FOR DIALYSIS, THEY NOTICED THE CATHETER WAS CLOGGED. THE PATIENT WAS BROUGHT BACK TO HAVE THE CATHETER REPLACED ON (B)(6) 2024. THERE WAS NO INJURY TO THE PATIENT. NO ADDITIONAL DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24723839 ↗InjuryMar 19, 2026Expulsion
THE CUSTOMER REPORTS PATIENT INITIALLY HAD A DIALYSIS CATHETER PLACED FEMORALY ON (B)(6) 2024. PATIENT WAS ADMITTED TO THE ICU AND WHEN RUNNING DIALYSIS, THE NURSE NOTICED THAT THE CATHETER HAD SLIPPED THROUGH THE ROTATING SUTURE WINGS AND WAS COMING OUTSIDE THE BODY IN THE GROIN AREA. THE PATIENT HAD TO HAVE THE CATHETER REPLACED. PATIENT WAS 4 FEET 9" WHICH IS WHY A SHORTER CATHETER WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24644212 ↗
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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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