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Titanium Needles 189989P01-00Recalls & reported problems

Nucletron B.V. · Trocar Ti Needle, 1.9mm, 60deg · Class 2

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717213050877), received between Apr 29, 2020 and Apr 29, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

  • Break1
  • Use of Device Problem1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 29, 2020Use of Device Problem; Break; Use of Device Problem

    THE CUSTOMER REPORTED THAT THE TIP OF THE TROCAR NEEDLE BROKE AND WAS STUCK INSIDE THE PATIENT. SURGICAL CAMERA WAS USED TO ASSIST THE REMOVAL OF THE TIP OF THE NEEDLE. THE PATIENT WAS DISCHARGED WITH AN ANTIBIOTIC MEDICINE.

    Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

    MAUDE report 10008721 ↗

Other System, applicator, radionuclide, remote-controlled devices

All System, applicator, radionuclide, remote-controlled devices →

Sources and updates

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