ReSolve ConvertX® 00884450458648Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450458648), received between Apr 6, 2022 and Apr 6, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2022Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT AFTER REMOVING A NEPHROURETERAL STENT FROM A MALE PATIENT'S RIGHT URETER, A METAL FOREIGN BODY WAS IDENTIFIED WITHIN THE PATIENT'S URETER. THE FOREIGN BODY WAS SUCCESSFULLY EXTERNALIZED VIA VASCULAR SNARE DEVICE. THE STENT WAS ORIGINALLY PLACED TO TREAT THE PATIENTS URETERAL STRICTURE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14024744 ↗
• MalfunctionApr 6, 2022Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT A NEPHROURETERAL DRAIN WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022 THE DRAIN WAS TO BE CONVERTED TO A NEPHROURETERAL STENT. DURING THE FINAL DEPLOYMENT, THE STENT PREMATURELY DETACHED AT AN UNEXPECTED LOCATION. THE PHYSICIAN STILL HAD ACCESS TO THE DEPLOYMENT STRING AND WAS ABLE TO REMOVE THE DEVICE WITHOUT PROCEDURAL INTERVENTION. A NEW NEPHROURETERAL STENT WAS PLACED FOR THIS PATIENT WITHOUT ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14024735 ↗