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Aspiration TubeRecalls & reported problems

Lumenis Ltd. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290109140629), received between Jul 20, 2023 and Aug 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity 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 16, 2026.

Most reported problems

Device problems

  • Material Integrity Problem2
  • Defective Device1

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.

  • MalfunctionAug 17, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE USE WAS DISCONTINUED BECAUSE OF A PROBLEM WITH THE DEMO CONSOLE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17569109 ↗
  • MalfunctionJul 20, 2023Defective Device; Material Integrity Problem; Defective Device; Material Integrity Problem

    IT WAS REPORTED THAT THE SUCTION TUBE FOR THE PROCEDURE WAS WORN OUT BY THE HEAT OF THE ROLLER PUMP, CAUSING THE TUBE TO CUT. THE SUCTION TUBE WAS CRACKED, AND POWDER WAS COMING OUT, AND THE SUCTION WAS NOT WORKING PROPERLY. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT WHOSE SEDATION STATUS WAS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17362144 ↗

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Sources and updates

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