Beacon N-22-05Recalls & reported problems
Covidien LP · FINE NEEDLE ASPIRATION NEEDLE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855208005063), received between Apr 11, 2023 and Apr 11, 2023 — classified as 1 injury.
5 other recalls cover devices cleared under the same FDA submission (K103668); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inflammation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT DEVELOPED PANCREATITIS AFTER HAVING THE MARKERS IMPLANTED. LAST PATIENT STATUS WAS UNKNOWN.
Patient problems: Inflammation
MAUDE report 16717901 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103668. One submission often covers many models, so check the product and lot details in each record.
- Z-1472-2017 · Feb 8, 2017 · TerminatedBNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
- Z-1474-2017 · Feb 8, 2017 · TerminatedSharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
- Z-1473-2017 · Feb 8, 2017 · TerminatedSharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
- Z-1476-2017 · Feb 8, 2017 · TerminatedBNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
- Z-1475-2017 · Feb 8, 2017 · TerminatedSharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
Other Biopsy needle devices
- MAGNUM MN1410Bard Peripheral Vascular, Inc. · Biopsy needle1 recall118 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4021Olympus Medical Systems Corp. · Biopsy needle1 recall94 reports
- EchoTip G31520Cook Ireland Ltd · Biopsy needle1 recall84 reports
- Single Use Aspiration Needle NA-201SX-4021Olympus Medical Systems Corp. · Biopsy needle1 death126 reports
- EchoTip ProCore G34785Cook Ireland Ltd · Biopsy needle97 reports
- MAGNUM MN1820Bard Peripheral Vascular, Inc. · Biopsy needle1 recall37 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4022Olympus Medical Systems Corp. · Biopsy needle1 recall29 reports
- Interject M00518250Boston Scientific Corporation · Biopsy needle70 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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