Achieve® 10884450443696Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Quick summary
This Merit Medical Achieve biopsy instrument is used to collect tissue samples during procedures such as breast biopsies. The 58 reports mostly describe the device failing to fire or failing to collect a sample, with surgeons sometimes unable to retrieve tissue despite repeated attempts and having to request a replacement. All58 reports are malfunctions with no deaths and no injuries. No recalls name this device. Reporting jumped sharply, from 5 reports in the previous 12 months to 53 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10884450443696), received between Jul 22, 2025 and Sep 24, 2026 — classified as 2 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (46 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 Fire46
- Failure to Obtain Sample6
- Patient Device Interaction Problem3
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions54
- Hemorrhage/Blood Loss/Bleeding2
- Pneumothorax1
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Insufficient Device Problem Information
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50892149 ↗InjurySep 24, 2026Insufficient Device Problem Information
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax
MAUDE report 50892111 ↗MalfunctionSep 21, 2026Failure to Obtain Sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848483 ↗MalfunctionMay 7, 2026Failure to Obtain Sample
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 25117168 ↗MalfunctionMar 26, 2026Patient Device Interaction Problem
DURING A BREAST BIOPSY, THE BREAST SURGEON WAS UNABLE TO RETRIEVE ANY TISSUE SAMPLES DESPITE MULTIPLE ATTEMPTS. THE BREAST SURGEON PROMPTLY REQUESTED A REPLACEMENT TO COMPLETE THE PROCEDURE. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698763 ↗MalfunctionMar 26, 2026Patient Device Interaction Problem
DURING A BREAST BIOPSY, THE BREAST SURGEON WAS UNABLE TO RETRIEVE ANY TISSUE SAMPLES DESPITE MULTIPLE ATTEMPTS. THE BREAST SURGEON PROMPTLY REQUESTED A REPLACEMENT TO COMPLETE THE PROCEDURE. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698752 ↗MalfunctionMar 26, 2026Patient Device Interaction Problem
DURING A PROCEDURE, THE PHYSICIAN FOUND A DEFECT IN THE SPRING AND WAS UNABLE TO COLLECT THE SAMPLE. THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT. NO PATIENT INJURY OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698749 ↗MalfunctionMar 3, 2026Failure to Obtain Sample; 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 24502288 ↗MalfunctionFeb 18, 2026Failure to Obtain Sample
THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO CAPTURE A BIOPSY SAMPLE NO SAMPLE COULD BE OBTAINED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24378120 ↗MalfunctionDec 23, 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 23878827 ↗MalfunctionDec 23, 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 23878826 ↗MalfunctionDec 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 23844946 ↗MalfunctionDec 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 23844927 ↗MalfunctionDec 15, 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 23810580 ↗MalfunctionDec 15, 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 23810573 ↗MalfunctionDec 15, 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 23810572 ↗MalfunctionDec 11, 2025Failure to Obtain Sample; Failure to Obtain Sample
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 23783263 ↗MalfunctionDec 11, 2025Failure to Obtain Sample; Failure to Obtain Sample
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 23783144 ↗MalfunctionNov 25, 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 23646519 ↗MalfunctionNov 25, 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 23646518 ↗MalfunctionNov 25, 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 23646517 ↗MalfunctionNov 25, 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 23646515 ↗MalfunctionNov 25, 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 23646512 ↗MalfunctionNov 25, 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 23646484 ↗MalfunctionNov 25, 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 23646483 ↗
Other INSTRUMENT, BIOPSY devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.