ReSolve ConvertX® 00884450458587Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450458587), received between Feb 15, 2022 and May 3, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 3, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE ACCOUNT ALLEGES THAT DURING THE NUMBER INSERTION, THE NEPHROURETERAL STENT SYSTEM CAME OUT COMPLETELY INSTEAD OF JUST 2 CENTIMETERS. THE PHYSICIAN HAD TO CUT THE CATHETER TO DISLODGE THE STENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860401 ↗
• InjuryFeb 15, 2022Difficult to Remove; Difficult to Remove

  THE ACCOUNT ALLEGES THAT DURING A CONVERTX DRAIN-TO-STENT CONVERSION, THE STENT WOULD NOT COMPLETELY DETACH FROM THE EXTERNAL SEGMENT. (INITIAL CONVERTX PLACEMENT (B)(6) 2022). IT IS ALLEGED THE CLINICIAN HAD PROCEEDED TO STEP 3 OF THE CONVERSION PROCESS WITHOUT INCIDENT. THE CLINICIAN DID NOT NOTE ANY EXTRA FORCE NEEDED OR RESISTANCE WHEN HE PULLED BACK ON THE RELEASE WIRE. THE INTERNAL/EXTERNAL SEGMENTS HAD APPEARED TO BE SEPARATED AND THE STENT DEPLOYED. HOWEVER, WHEN HE TRIED TO WITHDRAW THE DRAIN, THE INTERNAL SEGMENT MIGRATED ALONG WITH DRAIN. TWO DISTINCT SEGMENTS OF THE RELEASE WIRE WERE VISIBLE, ON BOTH THE INTERNAL AND EXTERNAL COMPONENTS. AN ATTEMPT TO MANIPULATE AND WITHDRAW THE DRAIN SEGMENT, WAS UNSUCCESSFUL. THE CLINICIAN PLANNED TO TEMPORARILY ABANDON THE PROCEDURE AND BRING THE PATIENT IN LATER THAT DAY. THE MERIT REP IMMEDIATELY REACHED OUT TO THE PRODUCT MANAGER WHO IN TURN LOOPED IN THE PRODUCT MANAGEMENT TEAM AND MET WITH THE CLINICIAN BEFORE THE SECOND PROCEDURE. BOTH THE MERIT REP AND PRODUCT MANAGEMENT TEAM WERE AVAILABLE AND CONFERENCED INTO THE PROCEDURE. THE CLINICIAN CAREFULLY REMOVED THE HUB OF THE CATHETER USING A SCALPEL AND EXPOSED SEVERAL CM'S OF BO

  Patient problems: Foreign Body In Patient

  MAUDE report 13538918 ↗