ReSolve® 00884450362976Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450362976), received between Mar 25, 2021 and Sep 25, 2024 — classified as 2 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2024Fracture; Fracture

  THE ACCOUNT ALLEGES THAT A PATIENT HAD AN 8.5FR RESOLVE DRAINAGE CATHETER PLACED ON AN UNKNOWN DATE. THE PATIENT RETURNED FOR A CATHETER EXCHANGE ON (B)(6) 2024. DURING REMOVAL OF THE RESOLVE DRAIN IT WAS NOTED TO NOT BE INTACT. THE PHYSICIAN REMOVED THREE SEPARATE PIECES OF THE DRAIN WHICH THEN WAS ABLE TO CONFIRM ENTIRE DRAIN WAS RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20300491 ↗
• MalfunctionApr 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ACCOUNT ALLEGES THAT WHILE CHANGING A PATIENT'S DRESSING, ON A DRAINAGE CATHETER, THE PLASTIC FITTING DISCHARGED FROM THE PROBE. A NEW DEVICE WAS IMPLANTED WITH NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701300 ↗
• InjuryMar 25, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A NEPHROSTOGRAM PROCEDURE THE DRAINAGE CATHETER THAT WAS PLACED ON (B)(6) 2021 WAS NOTED TO BE BROKEN. A NEW DRAINAGE CATHETER WOULD HAVE BEEN PLACED FOR THIS PATIENT. MEDICAL INTERVENTION WOULD HAVE BEEN NECESSARY. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572742 ↗