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DiLumen Endolumenal Interventional Platform, 103 cm DiLumen, 103 cmRecalls & reported problems

Lumendi LLC · DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. · Class 2

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 00865309000232), received between Jul 6, 2018 and Aug 22, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 18, 2026.

Most reported problems

Device problems

  • Use of Device Problem2

Patient problems

  • Bowel Perforation2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 22, 2018Use of Device Problem; Use of Device Problem

    DURING NAVIGATION WITH THE SCOPE AND THE DEVICE, A SIGMOID PERFORATION OCCURRED WHICH WAS REPAIRED DURING THE PROCEDURE WITH USE OF ENDOSCOPIC SUTURES. PATIENT WAS DISCHARGED IN TWO DAYS WITH NO FURTHER SEQUELAE. USER REQUESTED THAT THE INCIDENT NOT BE REPORTED AS DEVICE RELATED.

    Patient problems: Bowel Perforation

    MAUDE report 7805082 ↗
  • InjuryJul 6, 2018Use of Device Problem; Use of Device Problem

    A (B)(6) MALE WITH A HISTORY OF SEVERE SIGMOID DIVERTICULOSIS UNDERWENT COLONOSCOPY WITH AN OLYMPUS PEDIATRIC COLONOSCOPE AND THE DILUMEN DEVICE ON (B)(6) 2018. DURING NAVIGATION, RESISTANCE TO INTUBATION WAS ENCOUNTERED ON THE LEFT SIDE OF THE COLON DUE TO TORTUOUS ANATOMY. DURING CONTINUED ADVANCEMENT, THE SCOPE BOWED DOWNSTREAM OF THE SCOPE TIP AT THE LEVEL OF THE SIGMOID, CAUSING A PERFORATION IN THE SIGMOID. THE DEVICE AND SCOPE WERE REMOVED. AN ENDOLUMENAL SUTURING DEVICE WAS THEN USED TO CLOSE THE DEFECT AND THE PATIENT WAS ADMITTED. PATIENT EXPERIENCED SOME ABDOMINAL PAIN ON (B)(6) AND CT SCAN SUGGESTED POSSIBLE PERITONITIS. AN EXPLORATORY LAPAROTOMY WAS DONE ON (B)(6) 2018. THERE WAS NO PERITONITIS, BUT ONE STITCH DID NOT CLOSE THE COLON DEFECT COMPLETELY AND THE PATIENT UNDERWENT A SIGMOID COLECTOMY. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2018. EXAMINATION OF THE DILUMEN DEVICE BY THE MANUFACTURER REVEALED NO DEVIATION OF DEVICE SPECIFICATIONS AND NO EVIDENCE OF DEVICE FAILURE.

    Patient problems: Bowel Perforation

    MAUDE report 7667244 ↗

Other Colonoscope And Accessories, Flexible/Rigid devices

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Sources and updates

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