Solus G25671Recalls & reported problems
Cook Ireland Ltd · Solus, Double Pigtail Stent with Introducer · Class 2 · Implant
All models of Solus (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002256719), received between Aug 8, 2019 and Aug 17, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Dent in Material” (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.
Reports received per month
Most reported problems
Device problems
- Dent in Material1
- Device Damaged Prior to Use1
- Failure to Deliver1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Migration
Description of Event:The doctor is an experienced user of this product line, so user error has been completely ruled out.This doctor has encountered two cases where the stent spontaneously migrated and was expelled via the GI tract in less than one month post-placement.During placement, the stent was anchored deeply into the IHD.Although the product feature and indication specify a dwell time of up to 6 months, these stents migrated within just 1 month.The physician noted that migration never occurred with the previously used Zimmon stents.However, two of these double pigtail stents migrated within one month.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50272680 ↗MalfunctionApr 9, 2024Device Damaged Prior to Use; Dent in Material; Device Damaged Prior to Use; Dent in Material
A SLIGHT BENDING IS NOTICED AT ONE END OF THE PIGTAIL STENT UPON OPENING UP THE PACKAGING. RESISTANCE WAS FELT AND STUCKED AT THE BENDING PART WHILE INTRODUCING SOLUS INTRODUCER THROUGH THE DOUBLE PIGTAIL STENT. SECOND SET WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19069228 ↗MalfunctionAug 8, 2019Failure to Deliver; Failure to Deliver
DURING ERCP THE STENT BECAME STUCK IN THE SCOPE. 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'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8873553 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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