Solus G25672Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002256726), received between Feb 19, 2019 and Aug 17, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Migration

  Description of EventThe physician reported a cumulative total of 3 cases where the distal pigtail repeatedly eroded against the duodenal wall, causing duodenal ulcers.Patients began experiencing pain approximately one month post-placement, forcing the physician to perform premature stent removal.Currently, this stent is only available in a single thickness of 10Fr, with no other size options provided.It is unclear whether this issue stems from the product design (e.g., pigtail configuration/size) or material hardness (e.g., high durometer causing tissue erosion).Therefore, the physician has submitted a formal product complaint requesting a full investigation by the manufacturer.Patient/Event Info - NotesTRIAGE REQUESTED - (b)(6)2026:1. Please describe the storage conditions of the device prior to use especially those pertaining to temperature and light exposure.Room temperature 25 °C, storage in closet.2. What is the reorder number, diameter and length of the wire guide that was used with this device in this procedure?This problem occurred during the period of stenting. There were no reorder stent.3. Was the wire guide lubricated prior to use? "[N/A, Yes, No]"Yes.4. Was the wire gu

  Patient problems: Pain; Ulcer

  MAUDE report 50272695 ↗
• MalfunctionApr 7, 2020Difficult to Advance; Difficult to Advance

  AS REPORTED TO CUSTOMER RELATIONS: "CUSTOMER WENT TO DEPLOY STENT, AND GUIDING CATHETER STRETCHED AND MADE DEPLOYMENT IMPOSSIBLE. THE WHITE HUB CAME OFF THE CATHETER WHEN THEY TRIED TO DEPLOY. CUSTOMER HAD TO REMOVE ALL OF PRODUCT/DELIVERY SYSTEM; THEY COMPLETED THE PROCEDURE SOMEHOW, BUT UNKNOWN WITH WHAT SORT OF DEVICE. NO ADDITIONAL PROCEDURES REQUIRED, NO ADVERSE EFFECTS EXPERIENCED BY PATIENT, NOTHING REMAINING IN PATIENT, NO PROLONGED HOSPITALIZATION." DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. 2. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THE EVENT? NO IF YES, PLEASE DESCRIBE. 3. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO IF YES, PLEASE DESCRIBE. 4. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 5. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. 6. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9932697 ↗
• MalfunctionFeb 21, 2020Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance

  "PRODUCTS WOULDN'T WORK. ANY OF THE SOLUS DOUBLE PIGTAIL STENTS WITH INTRODUCERS WOULD NOT GO THROUGH THE WIRE LOCKS. "AS PER COMPLAINT FORM": WHEN TRYING TO USE THESE STENTS , THE STENT WOULD NOT FEED THROUGH THE WIRELOCK- IT WAS IMPOSSIBLE TO MOVE IT THROUGH AS THE STENT ISNT TAPPERED. WHEN WE REMOVED THE WIRELOCK IT WAS ALSO TOO DIFFICULT TO PUSH THE STENT INTO THE DUCT. FINISHED BY USING A 7FRENCH DOUBLE PIGTAIL STENT INSTEAD WHICH THE DOCTOR DIDNT WANT TO USE UNFORTUNATELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9737896 ↗
• MalfunctionFeb 10, 2020Difficult to Advance; Difficult to Advance

  THE USER IS UNSURE IF THE GUIDING CATHETER WAS LUBRICATED. WHEN PLACING THE BILIARY STENT, THE GUIDING CATHETER WAS PULLED AND IT STRETCHED/BROKE. DEVICE WAS REMOVED BY HAND. THE PROCEDURE WAS COMPLETED AS INTENDED WITH NO ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9685888 ↗
• MalfunctionFeb 19, 2019Material Deformation; Material Deformation

  THE NURSES WERE UNABLE TO PRELOAD IT AS THEY FELT THAT THERE WAS A SUBSTANCE INSIDE THE STENT THAT IS PREVENTING THE ADVANCEMENT OF STENT ON TO THE INTRODUCER. ANOTHER IDENTICAL REPLACEMENT PRODUCT WAS USED AND THE STENT WAS ABLE TO BE PRELOADED AND DEPLOYED SMOOTHLY. THE PRODUCT HAD AN ERROR EVEN BEFORE THE IT WAS PLACED INTO THE PATIENT FOR STENT DEPLOYMENT. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DIFFICULT ADVANCEMENT'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350040 ↗