Solus G25685Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002256856), received between May 22, 2018 and Apr 29, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionApr 29, 2021Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  THE INNER GUIDING CATHETER WAS NOT SEPARATED FROM THE PUSHING CATHETER(OUTER, COLOR IS PURPLE) WHEN THE STENT WAS TRIED TO BE PLACED IN THE BILE DUCT. THEY RE-STARTED STENT PLACED PROCEDURES, PLACED THE OTHER STENT ON THE BILE DUCT, AND FINISHED THE PROCEDURE. (THE STENT USED IS UNKNOWN). DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT BODY? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE(S)? NO. WERE THERE ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE ADVERSE EFFECT(S)? NO. PLEASE INDICATE WHERE THE DEVICE WAS STORED PRIOR TO USE. THIS PRODUCT WAS LOCATED IN THE ERCP ROOM PRIOR TO USE. WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? VISIGLIDE 2 GUIDEWIRE - OUTER DIAMETER 0.025IN / LENGTH 450CM / TIP SHAPE ANGLED / FIRST USE. WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE DEVICE OVER THE PARTICULAR WIRE GUIDE? IF YES PLEASE INDICATE THE PROCEDURE PERFORMED. SPHINCTEROTOMY. WAS THE WIRE GUIDE INSPECTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11743758 ↗
• MalfunctionJan 13, 2021Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11164179 ↗
• MalfunctionMay 22, 2018Difficult to Advance; Difficult to Advance

  INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿DIFFICULT ADVANCEMENT". AS REPORTED TO CUSTOMER RELATIONS, "TWO HOBBS FREEMAN 10X10 DOUBLE PIG TAIL STENTS WERE REMOVED FROM THE AMPULA. PHYSICIAN CANNULATED WITH A .035X450 JAG WIRE GUIDE THRU THE FUSION QUATRO EXTRACTION BALLOON. THREE SWEEPS OF THE BILE DUCT WERE PERFORMED AND PHYSICIAN LEFT THE LONG WIRE GUIDE IN POSITION AND HAD THE TECH PREPARE THE SOLUS 10X10 STENT FOR TRIAL. INTRODUCER GUIDING CATHETER WAS LIGHTLY LUBRICATED USING SURGI LUBE. STENT WAS LOADED ONTO GUIDING CATHETER AND THEN ONTO WIRE GUIDE. DIFFICULTY WAS EXPERIENCED ONCE IN THE DUCT GETTING THE STENT INTO POSITION. PHYSICIAN NOTED PUSHING CATHETER WAS BUCKLING AT THE BIOPSY PORT. GUIDING CATHETER WAS SLOWLY REMOVED ONCE THE PHYSICIAN HAD THE STENT INTO POSITION. GUIDING CATHETER STRETCHED AND BROKE MULTIPLE TIMES DURING REMOVAL. FINALLY, STENT WAS PLACED SUCCESSFULLY. PHYSICIAN WANTED TO PLACE A SECOND 10X10 DOUBLE PIG TAIL STENT, SO A HOBBS FREEMAN 10X10 DOUBLE PIGTAIL WAS LOADED ONTO A FUSION OASIS 10FR INTRODUCER. GUIDING CATHETER WAS LIGHTLY LUBED PRIOR TO STENT PLACEMENT. ONCE STENT INTO POSITION AND GUIDING CATHETER UP IN THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7533456 ↗