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
- NA 170003-24Nucletron B.V. · System, applicator, radionuclide, remote-controlled2 recalls0 reports
- Flexitron HDR 136149Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall3 reports
- Geneva 152022-00Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Geneva 152009-00Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Advanced Gynecological Applicator 126023-01Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Geneva 152024-00Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Advanced Gynecological Applicator 126019-01Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Advanced Gynecological Applicator 126022-01Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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