ReSolve® 00884450634905Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450634905), received between Jul 17, 2024 and Jul 17, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Gas/Air Leak” (2 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
- Gas/Air Leak2
Patient problems
- Air Embolism2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2024Gas/Air Leak; Gas/Air Leak
THE ACCOUNT ALLEGES THAT DURING A PNEUMOTHORAX DRAINAGE PROCEDURE, THE VALVE WAS ALLOWING AIR INTO THE PATIENT AS WELL. NO ADDITIONAL INTERVENTION WAS DEEMED NECESSARY. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: Air Embolism
MAUDE report 19762210 ↗InjuryJul 17, 2024Gas/Air Leak; Gas/Air Leak
THE ACCOUNT ALLEGES THAT DURING A PNEUMOTHORAX DRAINAGE PROCEDURE, THE VALVE WAS ALLOWING AIR INTO THE PATIENT AS WELL. NO ADDITIONAL INTERVENTION WAS DEEMED NECESSARY. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: Air Embolism
MAUDE report 19762209 ↗
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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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