ACHIEVE A149Recalls & reported problems
Carefusion 2200, Inc · ACHIEVE NEEDLE BIOP SOFT TISSUE 14GX9CM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403088384), received between Aug 13, 2025 and Sep 18, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (8 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Fire8
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2025Failure to Fire; Failure to Fire
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085435 ↗MalfunctionSep 18, 2025Failure to Fire; Failure to Fire
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085425 ↗MalfunctionSep 11, 2025Failure to Fire; Failure to Fire
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23027854 ↗MalfunctionSep 2, 2025Failure to Fire; Failure to Fire
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22940459 ↗MalfunctionAug 27, 2025Failure to Fire; Failure to Fire
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909978 ↗MalfunctionAug 13, 2025Failure to Fire; Failure to Fire
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22794316 ↗MalfunctionAug 13, 2025Failure to Fire; Failure to Fire
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22794289 ↗MalfunctionAug 13, 2025Failure to Fire; Failure to Fire
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE FAILED TO COLLECT A SAMPLE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22794277 ↗
Other INSTRUMENT, BIOPSY devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 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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