Achieve® 10884450443733Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884450443733), received between Jul 16, 2025 and Mar 26, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (12 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.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 24698755 ↗
• MalfunctionMar 11, 2026Patient Device Interaction Problem

  DURING A BREAST BIOPSY WITH ULTRASOUND GUIDANCE, THE HEALTHCARE PROVIDER WAS UNABLE TO DRAW BACK TO RETRIEVE SAMPLE FROM NEEDLE. TRIED AGAIN ONCE BIOPSY WAS COMPLETE, AND PT HAD LEFT THE ROOM AND WAS ABLE TO FORCE THE SAMPLE FROM THE NEEDLE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575387 ↗
• 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 24378077 ↗
• MalfunctionFeb 6, 2026Patient Device Interaction Problem

  DURING A BREAST BIOPSY WITH ULTRASOUND GUIDANCE, THE NEEDLE FAILED TO RETRIEVE CORE SAMPLES ON THE SECOND AND THIRD ATTEMPT. ONLY THE FIRST CORE WAS RETRIEVED ON THE AUTOMATIC FIRING MODE. A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277044 ↗
• 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 23845013 ↗
• 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 23845011 ↗
• 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 23844936 ↗
• 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 23844934 ↗
• MalfunctionDec 12, 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 23791743 ↗
• MalfunctionNov 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 23587263 ↗
• MalfunctionNov 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 23587262 ↗
• MalfunctionNov 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 23587259 ↗
• 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 23085487 ↗
• 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 23085475 ↗
• 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 23085445 ↗
• MalfunctionJul 29, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  THE ACCOUNT ALLEGES THE CLINCIAN FIRED THE DEVICE BUT COULD NOT TELL IF THE DEVICE HAD CLOSED. WHILE PULLING THE NEEDLE FROM THE PATIENT, IT WAS FELT THAT IT CLOSED. THE SAMPLE RETRIEVED WAS DEEMED INADEQUATE. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650582 ↗
• MalfunctionJul 29, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  THE ACCOUNT ALLEGES DURING A LEFT BREAST BIOPSY PROCEDURE, THE BIOPSY NEEDLE RETRIEVED INADEQUATE SAMPLES. A NEW NEEDLE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650581 ↗
• MalfunctionJul 22, 2025Failure to Fire; Failure to Fire

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE AXILLA BIOPSIES UNDER ULTRASOUND, MULTIPLE ATTEMPTS AND AN ADDITIONAL NEEDLE WERE NEEDED TO OBTAIN A CORE SAMPLE. PATIENT HAD FOUR CORES TAKEN INSTEAD OF NORMAL THREE TO OBTAIN AN ADEQUATE SAMPLE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566378 ↗
• InjuryJul 16, 2025Failure to Fire; Failure to Fire

  THE ACCOUNT ALLEGES THAT THE NEEDLE FAILED TO FIRE CORRECTLY AND THE PATIENT NEEDED EXTRA BIOPSIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522719 ↗