Solus G25673Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002256733), received between Feb 21, 2020 and Mar 24, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  WHEN PHYSICIAN PUSH STENT OVER THE STENOSIS, HE WANTED TO PULL BACK THE INNER CATHETER. HE FOUND THAT HE COULDN'T PULL BACK HE INNER CATHETER, HE USED FORCE TO IT AND LED THE CATHETER BROKEN. FINALLY, HE CHANGED TO COMPETITOR'S PLASTIC STENT, THEN IT'S OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672610 ↗
• MalfunctionJun 16, 2022Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  USER DETECTED THE PUSHER CANNOT BE PUT THROUGH STENT AT PREPARATION STAGE. NO USE ON PATIENT. N/A ¿ THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14712492 ↗
• MalfunctionFeb 25, 2021Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance

  SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE (B)(6) 2022.

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

  MAUDE report 11378767 ↗
• MalfunctionApr 6, 2020Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  AS REPORTED TO CUSTOMER RELATIONS: "2 EA DEVICES, DURING THE SAME PROCEDURE, HAD THE SAME FAILURE MODE. BOTH MADE PATIENT CONTACT BUT ONLY 1 EA IS AVAILABLE FOR RETURN (OTHER THROWN AWAY). DM EVALUATION OF RETURNABLE PRODUCT IS THAT THE PUSHING CATHETER KINKED DURING STENT ADVANCEMENT, AND WHEN THEY WERE TRYING TO DEPLOY THE GUIDING CATHETER THE WHITE CAP CAME OFF. PROCEDURE WAS COMPLETED WITH UNKNOWN DEVICE. NO ADD'L PROCEDURES REQUIRED, NO ADVERSE EFFECTS EXPERIENCED BY PATIENT, NOTHING REMAINING IN PATIENT, NO PROLONGED HOSPITALIZATION." .1 FOR ALL COMPLAINTS, ASK: 2.1.1 DOES THE COMPLAINT RELATE TO: DEVICE PLACEMENT (THIS ONE). DEVICE REMOVAL. OBSERVATION PRIOR TO PATIENT CONTACT. 2.1.2 PLEASE INDICATE WHERE THE DEVICE WAS STORED PRIOR TO USE. IN THE BOX, IN THE PROCEDURE ROOM IN A CABINET. 2.1.3 WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? UNKNOWN, EITHER .035 (BOSTON HYDROJAG) OR .025 (COOK). 2.1.4 WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE DEVICE OVER THE PARTICULAR WIRE GUIDE? ASKU. IF YES, PLEASE INDICATE THE PROCEDURE PERFORMED. 2.1.5 WAS THE WIRE GUIDE INS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9929091 ↗
• MalfunctionFeb 21, 2020Improper or Incorrect Procedure or Method; Material Twisted/Bent; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  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 9737810 ↗