ReSolve® 00884450009864Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450009864), received between Aug 18, 2021 and Aug 18, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training 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. 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.

• MalfunctionAug 18, 2021Labelling, Instructions for Use or Training Problem; Off-Label Use; Labelling, Instructions for Use or Training Problem; Off-Label Use

  THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER WAS PLACED WITHIN A PATIENT ON (B)(6) 2021. THE PATIENT TOLERATED THE PROCEDURE WELL. NO INJURY TO REPORT. DURING A SCHEDULED DRAINAGE CATHETER REPLACEMENT / FOLLOW-UP APPOINTMENT PROCEDURE ON (B)(6) 2021, THE CATHETER WAS FLUSHED WITH CONTRAST UNDER FLUOROSCOPY, AND A GUIDEWIRE WAS INSERTED FOR THE CATHETER EXCHANGE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER, IT WAS OBVIOUS THAT THE ORIGINAL DRAINAGE CATHETER HAD DETACHED WITHIN THE PATIENT'S BILIARY SYSTEM. THE ORIGINAL CATHETER WAS REMOVED, AND A NEW CATHETER WAS PLACED SUCCESSFULLY FOR THE PATIENT. THE DETACHED TIP WAS LEFT WITHIN THE PATIENT'S BILIARY SYSTEM. THE PHYSICIAN STATED THAT THE FOREIGN BODY WOULD PASS NATURALLY THROUGH THE PATIENTS GI TRACK. THE IFU STATES: THE DRAINAGE CATHETER IS NOT INTENDED FOR USE WITHIN THE BILIARY SYSTEM [OPERATOR "USE ERROR"]. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12338994 ↗