ReSolve® 00884450362969Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450362969), received between Sep 4, 2023 and Sep 4, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER WAS USED ON A PATIENT FOR THE TREATMENT OF CHOLECYSTITIS. THE INSERTION OF THE DEVICE SEEMED SUCCESSFUL, HOWEVER, DURING A SCHEDULED PROCEDURE FOR THE DRAIN REMOVAL, CLINICAL STAFF REPORTED THAT THIS WAS PARTICULARLY DIFFICULT TO REMOVE, PARTICULARLY WITH THE UNLOCKING OF THE CAP TO RELEASE THE DRAIN. THE PATIENT SUBSEQUENTLY ATTENDED THE EMERGENCY DEPARTMENT, AND IT WAS LATER IDENTIFIED THAT THE PATIENT HAD A GALLBLADDER PERFORATION. THE PATIENT UNDERTOOK A LAPAROTOMY AND WAS CARED FOR IN ITU FOR 14 WEEKS. THE INSTRUCTIONS FOR USE STATE THAT THE RESOLVE LOCKING DRAINAGE CATHETER IS NOT TO BE USED IN THE BILIARY SYSTEM.

  Patient problems: Internal Organ Perforation

  MAUDE report 17680511 ↗