ACHIEVE A1411Recalls & reported problems
Carefusion 2200, Inc · ACHIEVE NEEDLE BIOP SOFT TISSUE 14GX11CM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885403088346), received between Aug 13, 2025 and Nov 6, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (9 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Fire9
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
DURING A BREAST BIOPSY USING THE ACHIEVE BIOPSY NEEDLE, THE RELEASE FIRING MODE WAS VERY WEAK RESULTING IN NO SAMPLE CAPTURES. THE CUSTOMER INDICTED THAT THEY BELIEVED THE SPRING COULD HAVE BEEN DEFECTIVE. A DIFFERENT NEEDLE FROM ANOTHER LOT WAS THEN USED AND WAS REPORTED TO WORK WELL. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487920 ↗MalfunctionNov 3, 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 23458586 ↗MalfunctionNov 3, 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 23458573 ↗MalfunctionNov 3, 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 23458405 ↗MalfunctionNov 3, 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 23458383 ↗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 22910000 ↗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 22909996 ↗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 22909974 ↗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 22909966 ↗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 22794317 ↗
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- 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 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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