ReSolve® 00884450009857Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450009857), received between Aug 12, 2020 and Sep 1, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (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. 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.

• MalfunctionSep 1, 2021Failure to Deliver; Failure to Infuse; Failure to Deliver; Failure to Infuse

  THE ACCOUNT ALLEGES THAT WHEN FLUSHING A PLEURAL DRAINAGE CATHETER THAT WAS PLACED WITHIN A PATIENT AT A LATER DATE, A TINY HOLE WAS NOTICED NEAR THE HUB OF THE CATHETER. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE DEVICE USE WAS DISCONTINUED. A NEW DEVICE WAS NOT PLACED WITHIN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407356 ↗
• MalfunctionOct 27, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A DRAINAGE TUBE REMOVAL PROCEDURE, THE BILIARY DRAINAGE TUBE DETACHED WITHIN THE PATIENT BILIARY SYSTEM. AN ATTEMPT TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT WAS NOT MADE. THE ACCOUNT BELIEVES THAT THE DETACHED PIECE WILL NATURALLY PASS THROUGH THE PATIENT'S GI TRACK AND WILL BE NATURALLY DISCHARGED. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10741825 ↗
• MalfunctionAug 12, 2020Off-Label Use; Off-Label Use

  THE ACCOUNT ALLEGES THAT A DRAINAGE SYSTEM WAS IMPLANTED FOR THE TREATMENT OF BILLIONS OF DIGESTIVE STENOSIS AND AFTER 8 WEEKS A LEAK WAS NOTED. WHEN PERFORMING RX THE PRODUCT WAS NORMAL AND POSITIONED CORRECTLY. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS SCHEDULED FOR WITHDRAWAL ON (B)(6). ON THE DATE, AT THE TIME OF THE INITIAL FLUOROSCOPY TO REMOVE THE MATERIAL, THE FRAGMENTATION OF THE PRODUCT WAS CONFIRMED. DUE TO WHAT HAPPENED, THE DRAIN WAS CHANGED (AND NOT REMOVED), THE TREATMENT WAS EXTENDED FOR ANOTHER TWO WEEKS. THE FRAGMENTS WERE REMOVED WITH A LOOP CATHETER. THE PATIENT IS FINE. DOCTOR REQUESTED AN OPINION FROM THE COMPANY. PRODUCT MANAGER (B)(6) REPORTED HAVING CONTACTED THE DOCTOR OVER THE PHONE AND IN CONVERSATION, INDICATED THAT THIS CATHETER IS NOT SUITABLE FOR THIS TYPE OF IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10398854 ↗