Geenen Sof-Flex G49668Recalls & reported problems
Cook Ireland Ltd · Geenen Sof-Flex Pancreatic Stent · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002496689), received between Aug 14, 2023 and Aug 17, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Manufacturing, Packaging or Shipping Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2023Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event; Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event
THE INCORRECT STENT WAS INSIDE PACKAGING. THE STENT INTENDED TO BE PLACED WAS A G49668 FROM LOT NUMBER C1994025. HOWEVER, THE STENT IN THE PACKAGING HAS INTERNAL FLANGES (THE PRODUCT DETAILS ARE UNKNOWN AT THIS TIME; THE PRODUCT IS BEING RETURNED FOR EVALUATION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17564539 ↗InjuryAug 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE INCORRECT STENT WAS INSIDE PACKAGING. THE STENT INTENDED TO BE PLACED WAS A G49668 FROM LOT NUMBER C1994025. HOWEVER, THE STENT IN THE PACKAGING HAS INTERNAL FLANGES (THE PRODUCT DETAILS ARE UNKNOWN AT THIS TIME; THE PRODUCT IS BEING RETURNED FOR EVALUATION). THE INCORRECT STENT WAS REMOVED, AND THE CORRECT STENT WAS PLACED WITHOUT ISSUE. NO HARM TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17540340 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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