Johlin G26830Recalls & reported problems
Cook Ireland Ltd · Johlin, Pancreatic Wedge Stent · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002268309), received between Feb 27, 2019 and Feb 27, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.
Most reported problems
Device problems
- Device Damaged Prior to Use1
- Off-Label Use1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2019Off-Label Use; Device Damaged Prior to Use; Off-Label Use; Device Damaged Prior to Use
BEFORE OPENING THE DEVICE, A DEGRADATION OF THE SHEATH IS NOTICED JUST AFTER THE TUOHY-BORST ADAPTER. THE PLASTIC IS BROKEN AND THERE IS NO JUNCTION ANYMORE BETWEEN THE SHEATH AND THE ADAPTER. THE SURGEON HAD EXPERIENCE SO HE STILL MANAGED TO PERFORM THE PROCEDURE WITH THE SAME DEVICE. DEVICE NOT KEPT BUT PHOTOS ARE AVAILABLE. PATIENT INJURY TO BE CONFIRMED. INCIDENT WAS NOT DECLARED TO THE ANSM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8373254 ↗
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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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