Duette G35129Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002351295), received between Apr 28, 2017 and Oct 28, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Break; Structural Problem; Break; Structural Problem

  DESCRIPTION OF EVENT. RETURNED DEVICE MISSING BLUE HOOK. DEVICE RETURNED WITH BLUE HOOK DETACHED FROM LOADING CATHETER ¿ RPN AND LOT NUMBER DIFFERENT FROM THOSE REPORTED IN (B)(6) AND (B)(6). THIS FILE CAPTURES 2 DEVICES THAT WERE RETURNED FOR LABORATORY EVALUATION UNDER RPN DT-6-5F AND LOT C2311159. PATIENT OUTCOME. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401603 ↗
• MalfunctionSep 2, 2025Break; Structural Problem; Break; Structural Problem

  A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 24-SEP-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937743 ↗
• MalfunctionSep 14, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  PER REP - ON (B)(6) 2023 - WHEN THEY WERE DOWN IN THE STOMACH AREA THAT THEY WANTED TO TREAT, THEY WENT TO RELEASE ONE BAND BUT ALL SIX DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. 6.3.1.1 DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? -NO. IF YES, PLEASE DESCRIBE. 6.3.1.2 WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE? -NO. 6.3.1.3 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? -NO. IF YES, PLEASE DESCRIBE. 6.3.1.4 DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? -NO. IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. 6.3.1.5 HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? -NO. 6.3.1.6 HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? -NO. PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. 1.0 RPN PREFIX: DT. 1.1 GENERAL QUESTIONS. 1.1.1 PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE. -STOMACH. 1.1.2 WHAT MAKE & MODEL OF ENDOSCOPE WAS USED? -OLYMPUS. 1.1.3 WAS A DISPOSABLE CAP USED AT THE BIOPSY PORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743087 ↗
• InjuryJul 29, 2021Fracture; Structural Problem; Fracture; Structural Problem

  SUPPLEMENTAL REPORT IS BEING SUBMITTED AS A CORRECTION REPORT - IMDRF CODING AND THE ADDITIONAL MFG NARRATIVE-NOTES HAVE BEEN UPDATED TO REFLECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12245237 ↗
• InjuryJul 23, 2021Fracture; Fracture

  ACCORDING TO THE INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN EGD PROCEDURE IN WHICH THE DUETTE MULTI-BAND MUCOSECTOMY DEVICE, G35129, WAS USED. THIS PROCEDURE WAS THE FIRST TIME THE TECH USED THIS DEVICE AND HAD THE ASSISTANCE OF THE PHYSICIAN LOADING ONTO THE SCOPE APPROPRIATELY. AS THE DEVICE WAS ADVANCED INTO THE MOUTH THE STRING COMPLETELY BROKE CAUSING ALL SIX OF THE BANDS TO COME OFF JUST ABOVE THE PATIENTS AIRWAY. MULTIPLE INTERVENTIONS, X-RAYS AND BRONCHOTOMY, WERE DONE DURING THE PROCEDURE TO ENSURE NO BANDS WERE IN THE AIRWAY OR LUNGS. THE PHYSICIAN WAS ABLE TO ACCOUNT FOR ALL OF THE BANDS EXCEPT FOR ONE. FOUR BANDS WERE LOCATED IN THE PATIENTS MOUTH AND THROAT. THE FIFTH BAND WAS LOCATED EXTERNALLY OF THE PATIENT. AND THE SIXTH BAND WAS NOT FOUND INTERNALLY OR EXTERNALLY OF THE PATIENT. NO BANDS WERE LOCATED IN THE AIRWAY NOR IN THE LUNGS DURING THE BRONCHOTOMY. THE PHYSICIAN AS THE PROCEDURE HAD ALREADY BEEN DISRUPTED STOPPED THE PROCEDURE AND DID NOT CONTINUE AT THIS TIME. NO PLANS TO RESCHEDULE WERE MADE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 12217296 ↗
• MalfunctionAug 29, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A PATIENT UNDERWENT AN EMR- ENDOSCOPIC MUCOSAL RESECTION PROCEDURE IN WHICH ONE DUETTE MULTI-BAND MUCOSECTOMY DEVICE, G35129, WAS USED. THE BANDS WERE GRABBING THE STRING; THE STRING WAS BETWEEN THE TISSUE AND THE BANDS. THE PHYSICIAN WAS ABLE TO GET THREE (3) BANDS AROUND THE TUMOR. THEN REMOVED THE ENTIRE SCOPE TO CUT THE STRING TO RELEASE. THEN WENT DOWN WITH A SNARE TO RELEASE THE TUMOR. FDA MDR REPORTING REQUIRED: EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿DEPLOYMENT - BEADED STRING TWISTED'. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946178 ↗
• InjuryAug 7, 2019Failure to Capture; Failure to Capture

  DEVICE WAS IMPLEMENTED IN STOMACH AND DAMAGED INNER STOMACH LINING, BLEEDING OCCURRED "AS PER COMPLAINT FORM": 3 NEUROENDOCRINE TUMOURS IN STOMACH, SMALLEST ONE AT CARDIA WAS TAKEN AWAY WITH DUETTE, SECOND TUMOUR SIZE 5-6MM AT THE UPPER PART OF THE CORPUS, WASN'T SUBCUTANEOUSLY INJECTED, CANNOT REMEMBER IF HE CUT ABOVE OR UNDERNEATH, PERFORATED, WAS CLOSED WITH OTSC CLIP, THIRD TUMOUR IN ANTRUM TAKEN AWAY SUPERFICIALLY FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS THE PATIENT'S INNER STOMACH LINING WAS DAMAGED AND INTERVENTION WAS REQUIRED TO STOP THE BLEEDING (PERFORATED, WAS CLOSED WITH OTSC CLIP).

  Patient problems: Perforation

  MAUDE report 8868520 ↗
• MalfunctionApr 25, 2019Off-Label Use; Off-Label Use

  THE DOCTOR HAD REMOVED 5 SECTIONS OF 3 SEPARATE NODULES. 1 BAND REMAINED. DUE TO MINOR BLEEDING, THE SNARE WAS ALSO USED FOR SOFT COAG OF SOME VERY SMALL VESSELS. IT WAS NOTED THAT THE SECOND NODULE WAS MORE DIFFICULT TO RESECT DUE TO THICKENING OF THE MUCOSA DUE TO PREVIOUS TREATMENTS (HALO AND EMR). WHILE ATTEMPTING TO DO FURTHER SOFT COAG FOR BLEEDING AFTER THE 5TH RESECTION, THE SNARE TIP CAME OUT OF THE SHEATH AND THE WIRE APPEARED BROKEN. ANOTHER SNARE WAS USED TO COMPLETE THE PROCEDURE. NO MORE RESECTIONS WERE NEEDED. ON CLOSER INSPECTION THE SNARE WAS NOT COMPLETELY BROKEN , BUT ONE STRAND OF WIRE HAD BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8549756 ↗
• MalfunctionApr 28, 2017Defective Component; Defective Component

  THIS FOLLOW UP MDR IS BEING SUBMITTED AS THE DEVICE WAS RETURNED AND EVALUATED. CUSTOMER LOADED DUETTE DEVICE ONTO ENDOSCOPE (GIF-H190). DUETTE WAS SUCCESSFULLY USED TO BAND NODULE. SNARE WAS ADVANCED DOWN THE ACCESSORY CHANNEL OF THE ENDOSCOPE. SNARE WAS PLACED AROUND NODULE. SNARE WAS ATTACHED TO ACTIVE CORD AND CAUTERY WAS APPLIED. CUTTING WAS "DELAYED" PER STAFF, THOUGH IT DID EVENTUALLY CUT THROUGH THE NODULE. STAFF THEN NOTED DEFECT OF THE SNARE CATHETER PROXIMAL TO THE HANDLE, AS PICTURES DEMONSTRATE. STAFF OPENED A NEW DUETTE KIT IN ORDER TO REPLACE THE 5FR. SNARE THAT WAS DEFECTIVE. THEY THEN PROCEEDED WITH THE PROCEDURE WITHOUT ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6528792 ↗