ReSolve ConvertX®Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 13, 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 00884450721285), received between Nov 26, 2025 and Nov 26, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Integrity Problem2
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.
MalfunctionNov 26, 2025Break; Material Integrity Problem; Break; Material Integrity Problem
THE ACCOUNT ALLEGES THAT A PATIENT CAME IN FOR A TWO WEEK FOLLOW UP AFTER A CONVERSION FROM DRAIN TO BILATERAL STENT. UPON INITIAL IMAGE THE PROVIDER OBSERVED THAT BOTH SIDES LOOKED TO HAVE BEEN CUT OR SEPARATED AT A LOCATION OTHER THAN WHERE IT IS INTENDED TO DETACH. THE PROVIDER ATTEMPTED TO DETACH THE RIGHT SIDE AND AFTER FOLLOWING ALL APPROPRIATE STEPS THE DEVICE DID NOT CONVERT. THE PHYSICIAN DID NOT ATTEMPT TO CONVERT ON THE LEFT SIDE AS THEY COULD SEE IT HAD ALREADY SEPARATED IN A LOCATION OTHER THAN THE INTENDED SPOT. NO PATENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23658622 ↗MalfunctionNov 26, 2025Break; Material Integrity Problem; Break; Material Integrity Problem
THE ACCOUNT ALLEGES THAT A PATIENT CAME IN FOR A TWO WEEK FOLLOW UP AFTER A CONVERSION FROM DRAIN TO BILATERAL STENT. UPON INITIAL IMAGE THE PROVIDER OBSERVED THAT BOTH SIDES LOOKED TO HAVE BEEN CUT OR SEPARATED AT A LOCATION OTHER THAN WHERE IT IS INTENDED TO DETACH. THE PROVIDER ATTEMPTED TO DETACH THE RIGHT SIDE AND AFTER FOLLOWING ALL APPROPRIATE STEPS THE DEVICE DID NOT CONVERT. THE PHYSICIAN DID NOT ATTEMPT TO CONVERT ON THE LEFT SIDE AS THEY COULD SEE IT HAD ALREADY SEPARATED IN A LOCATION OTHER THAN THE INTENDED SPOT. NO PATENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23658616 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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