Solus G25670Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002256702), received between Feb 28, 2018 and Dec 1, 2025 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Failure to Advance; Failure to Advance

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 23-JAN-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23689591 ↗
• InjuryDec 15, 2023Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  ON (B)(6) 2023 USER WAS CONDUCTING GASTROINTESTINAL ENDOSCOPY EXAMINATION AND TREATMENT. USER TOOK 10FR STENT WITH 3.7MM ENDOSCOPE TO CONDUCT BILE DRAINAGE ACCORDING TO IFU INSTRUCTION. DURING THE PROCEDURE, USER ADVANCED THE STENT INTO ENDOSCOPE WORKING CHANNEL SUCCESSFULLY , BUT CANNOT ADVANCED THE STENT THROUGH THE DISTAL END OF WORKING CHANNEL, AND THE STENT PUSHER WAS STUCK INSIDE THE ENDOSCOPE WORKING CHANNEL AND CANNOT MOVE FORWARD. USER HAS 2 CHOICES AT THE MOMENT, ONE IS CHANGE A SMALLER SIZE OF STENT (7FR), OR CHANGED A BIGGER DIAMETER ENDOSCOPE. BUT USER CONSIDER THE 3.7MM ENDOSCOPE IS MORE CONVENIENT TO PROCEED THE PROCEDURE, AND CHANGED ENDOSCOPE REQUIRES MORE TIME AND MORE COMPLICATED, USER DECIDED TO CHANGE THE SENT TO CONTINUE THE PROCEDURE. THIS KIND OF PROCEDURE NORMALLY COMPLETED IN 2 HOURS, BUT THIS PROCEDURE WAS COMPLETED USING 7 HOURS. USER OBSERVED THE PATIENT OUTCOME THROUGH THE PROCEDURE WHICH IS WELL. AND THE PATIENT RECOVERS WELL AFTER PROCEDURE, NO HARM TO PATIENT. USER REPORTED THE AE TO NATIONAL AE SYSTEM AS IT IS PROLONG THE PROCEDURE SERIOUSLY. PATIENT OUTCOME: THE PROCEDURE PROLONG 5 HOURS THAN USUAL. PATIENT IS WELL DURING PROCEDURE AND RECOVERS WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18335200 ↗
• MalfunctionOct 31, 2019Difficult to Advance; Difficult to Advance

  FDA MDR REPORTING REQUIRED - EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'. AS REPORTED TO CUSTOMER RELATIONS VIA PHONE CONVERSATION "THE DEVICE FAILED TO DEPLOY WHEN THE PHYSICIAN TRIED TO DEPLOY IT. A SECOND G25670-ZSS-10-3-RB WAS OPENED AND USED TO COMPLETED THE PROCEDURE SUCCESSFULLY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9260394 ↗
• MalfunctionFeb 28, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS MDR IS BEING SUBMITTED AS A CORRECTION, BASED ON ADDITIONAL INFORMATION AND CLINICAL INPUT RECEIVED THERE WAS NO HARM TO THE PATIENT. THIS REPORT HAS BEEN RE-CATEGORIZED AS A MALFUNCTION REPORT ONLY. CONFIRMATION WAS RECEIVED THAT THE MARKERS FELL INTO THE STOMACH AND WERE EXCRETED FROM THE BODY NATURALLY. CLINICAL INPUT WAS RECEIVED (B)(6) 2018: WOULD YOU BE ABLE TO GIVE YOUR CLINICAL INPUT ON THE POTENTIAL HARM TO THE PATIENT BY EXCRETING THE RADIOPAQUE MARKERS? THERE IS NO HARM IF THE MARKERS WERE EXPELLED NATURALLY. AS REPORTED TO CUSTOMER RELATIONS, "THE RADIOPAQUE MARKERS CAME OFF THE SOLUS STENT DURING INSERTION. THE PHYSICIAN LEFT THE STENT IN PLACE AND THE MARKERS FELL INSIDE THE STOMACH. THE PHYSICIAN SPRAYED THE INTRODUCER WITH SILICONE BEFORE HAND."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7303289 ↗