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LesionHunter(TM) Rotatable Nitinol Cold Snare CS2-21523231Recalls & reported problems

Micro-Tech (Nanjing) Co., Ltd. · Oval Snare loop, Rotatable, Coated spring tube, Nitinol wire Snare loop, Diameter of Snare loop is 15 mm, working length is 2300mm, the maximum outside diameter of the insertion part is 2.3mm · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 06932503550062), received between Jan 2, 2024 and Jan 16, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break4

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 16, 2025Break; Break

    ON JANUARY 3, 2025. MICRO-TECH RECEIVED 2 REPORTS REGARDING COLD SNARE OF MICRO-TECH(NANJING) CO., LTD. MEDWATCH REPORT #: MW5163519.THIS IS THE SECOND REPORT. IT WAS REPORTED THAT "DEVICE BROKE WHILE USING DURING A PROCEDURE- SECOND DEVICE OF THE SAME LOT NUMBER WAS DEPLOYED AND ALSO BROKE IN THE SAME FASHION. BOTH DEVICES WERE THE LESION HUNTER REF NUMBER: CS2-21523231, LOT NUMBER: M240417302. REFERENCE REPORT: MW 5163518. "

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21166452 ↗
  • MalfunctionJan 16, 2025Break; Break

    ON JANUARY 3, 2025. MICRO-TECH RECEIVED 2 REPORTS REGARDING COLD SNARE OF MICRO-TECH(NANJING) CO.,LTD. MEDWATCH REPORT #: MW5163518. IT WAS REPORTED THAT "DEVICE BROKE WHILE USING DURING A PROCEDURE- SECOND DEVICE OF THE SAME LOT NUMBER WAS DEPLOYED AND ALSO BROKE IN THE SAME FASHION. BOTH DEVICES WERE THE LESION HUNTER REF NUMBER: CS2-21523231, LOT NUMBER: M240417302. REFERENCE REPORT #: MW5163519."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21166451 ↗
  • MalfunctionNov 20, 2024Break; Break

    ON NOVEMBER 12, 2024, MICRO-TECH CHECKED THE MAUDE WEBSITE AND FOUND A MDR REPORT REGARDING COLD SNARE OF MICROTECH(NANJING) CO., LTD. MDR REPORT #: MW5161508. IT WAS REPORTED THAT 15 MM LESION HUNTER ROTATABLE NITINOL COLD SNARE LOT: M240116301. LESION HUNTER SIZE 15 MM SNARE SNAPPED IN HALF WHEN RETRIEVING POLYP.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20731795 ↗
  • MalfunctionJan 2, 2024Break; Break

    ON 12/26/2023, MICRO-TECH RECEIVED A MDR REPORT NOTIFICATION FROM FDA. USER FACILITY REPORT #: (B)(4).. IT WAS REPORTED THAT "A LESIONHUNTER SNARE BROKE DURING A POLYPECTOMY IN THE PATIENT. THE SNARE WAS REMOVED WITHOUT INCIDENT. SNARE SAVED FOR FUTURE EXAMINATION."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18423867 ↗

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Sources and updates

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