Johlin G26831Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002268316), received between Feb 27, 2020 and Jun 29, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (4 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.

• MalfunctionJun 29, 2021Off-Label Use; Off-Label Use

  THIS FILE IS BEING OPENED TO CAPTURE THE OFF LABEL USE OF THE REPLACEMENT JPWS STENT USED IN (B)(4) AS PER ANSWERS TO ADDITIONAL QUESTIONS RECEIVED ON 03-JUNE-21: IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? IMPLANTATION OTHER JPWS STENT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. BILIARY ERCP- HILAR STENOSIS THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE AS RECIEVED ON 03-JUNE-21: DOES THE COMPLAINT RELATE TO DEVICE REPLACEMENT, DEVICE REMOVAL OR WAS IT AN OBSERVATION MADE PRIOR TO PATIENT CONTACT? PLACEMENT IN THE PATIENT. . WHAT WAS THE TARGET LOCATION FOR THE STENT? BILIARY STENOSIS . PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. STORAGE WITHOUT LIGHT . WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE?BOSTON WIRE GUIDE REVOLUTION360° O,25INCH . WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES . WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082486 ↗
• MalfunctionMay 26, 2021Off-Label Use; Off-Label Use

  FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 20-AUG-21

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885333 ↗
• MalfunctionJul 27, 2020Off-Label Use; Off-Label Use

  CANCELLATION REPORT BEING SUBMITTED AS (B)(4) (EMDR 3001845648-2020-00458) WAS CREATED TO CAPTURE OFF-LABEL OF TWO PANCREATIC STENTS BEING PLACED IN BILE DUCT AS OUTLINED IN (B)(4) (3001845648-2020-00130) . HOWEVER THIS OFF LABEL USE WILL NOW BE CAPTURED UNDER THE FINAL REPORT OF ORIGINAL FILE OF(B)(4) (3001845648-2020-00130). CURRENT PR NO LONGER REQUIRED.

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

  MAUDE report 10327230 ↗
• MalfunctionMar 26, 2020Use of Device Problem; Use of Device Problem

  THIS FOLLOW UP IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9883768 ↗
• MalfunctionFeb 27, 2020Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component

  FINAL MDR BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 16-AUG-21. AN ERCP WAS BEING PERFORMED WHERE TWO PREVIOUSLY PLACED ZILVER STENTS ARE IN PLACE IN THE LEFT AND RIGHT HILUM. THE USER CANNULATED BOTH SIDES WITH 2 DIFFERENT WIRES AND BALLOON SWEEPS WERE PERFORMED. AN EXTRACTION BALLOON WAS USED TO REMOVE SOME TUMOR INGROWTH. THE 6MM TITAN BALLOON WAS USED TO DILATED BOTH SIDES. TWO JOHLIN PANCREATIC WEDGE STENTS WERE PLACED. WHILE THE USER WAS DEPLOYING ONE OF THE STENTS, PULLING BACK ON THE GUIDING CATHETER, THE WHITE KNOB ON THE END OF THE GUIDING CATHETER RIPPED OFF. THE USER WAS ABLE TO DEPLOY THE STENT BY HOLDING ONTO THE BLACK PORTION OF THE CATHETER. THE STENT WAS PLACED SUCCESSFULLY. DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION? NO. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO. DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVE

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

  MAUDE report 9762540 ↗