ReSolve ConvertX® 00884450721308Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450721308), received between Jan 24, 2024 and Sep 30, 2026 — classified as 1 injury, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture1
- Material Separation1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947121 ↗MalfunctionMay 27, 2026Break
CUSTOMER REPORTED THAT WHILE REMOVING THE DEVICE, THE DRAINAGE PORTION OF THE CONVERTX CATHETER FRACTURED DURING CONVERSION. THE DRAINAGE PORTION WAS SUCCESSFULLY REMOVED. THE STENT PORTION WAS INSPECTED AND SHOWED NO DEFECTS.THERE WAS NO PATIENT INJURY OE MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302723 ↗InjuryMar 19, 2025Break; Fracture; Break; Fracture
THE ACCOUNT ALLEGES THAT WHEN PULLING THE CATHETER OUT OF THE PATIENT, THE STENT CAME WITH IT. THE PLASTIC BEADS IN TWO AND THREE BROKE AND THE WIRE RIPPED OFF. UROLOGY HAD TO PERFORM A CYSTOSCOPY TO RETRIEVE THE CATHETER AND PLACE A NEW ONE.
Patient problems: Foreign Body In Patient
MAUDE report 21644400 ↗MalfunctionJan 24, 2024Separation Failure; Separation Failure
THE ACCOUNT ALLEGES THAT THE STENT WOULD NOT ENGAGE. A NEW DEVICE WAS DEPLOYED WITHIN THIS PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18571182 ↗
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- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
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- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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