ReSolve® 00884450685150Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
All models of ReSolve (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450685150), received between Mar 4, 2025 and Jul 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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
- Difficult or Delayed Positioning1
- Difficult to Remove1
- Fracture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Difficult to Remove; Difficult to Remove
THE ACCOUNT ALLEGES THEY COULD NOT REMOVE THE PLASTIC STIFFENING CANNULA. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22647427 ↗MalfunctionMar 4, 2025Difficult or Delayed Positioning; Fracture; Material Separation; Difficult or Delayed Positioning; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT WHILE ATTEMPTING TO MANIPULATE DEVICES THROUGH THE CATHETER. WHEN ATTEMPTING TO REMOVE THE DEVICES FROM THE CATHETER, THE COMPONENTS BECAME STUCK AND BROKE OFF INSIDE THE CATHETER. THE CATHETER AND BROKEN COMPONENTS WERE REMOVED TOGETHER. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21518943 ↗
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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 13, 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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