iNod™ Ultrasound Guided Biopsy Ne M00502060Recalls & reported problems
Boston Scientific Corporation · Biopsy Needle · Class 2
Data updated Oct 18, 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 00191506020729), received between Dec 12, 2024 and Dec 12, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INOD ULTRASOUND GUIDED BIOPSY NEEDLE WAS TO BE USE IN A INOD NAVIGATIONAL BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE PACKAGE WAS FOUND PARTIALLY OPENED. THEY COULDN'T USE THE DEVICE AND COMPLETED THE PROCEDURE BY OPENING A NEW ONE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20910646 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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