Achieve® 10884450443757Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884450443757), received between Aug 14, 2025 and Sep 15, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Obtain Sample” (3 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Failure to Obtain Sample

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781547 ↗
• 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 24378122 ↗
• 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 24378118 ↗
• 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 23845100 ↗
• MalfunctionNov 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ACCOUNT ALLEGES THAT DURING AN ULTRASOUND BIOPSY OF THE KIDNEY, THE DEVICE DID NOT COLLECT AND TISSUE SAMPLES ON THREE ATTEMPTS. THE DOCTOR ABANDONED PROCEDURE AND THE PATIENT WILL RETURN FOR AN ADDITIONAL BIOPSY IN INTERVENTIONAL RADIOLOGY AT A LATER DATE. NO REPORTED PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479237 ↗
• MalfunctionNov 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ACCOUNT ALLEGES THAT DURING AN ULTRASOUND BIOPSY OF THE KIDNEY, THE DEVICE DID NOT COLLECT AND TISSUE SAMPLES ON THREE ATTEMPTS. THE DOCTOR SWITCHED TO A DIFFERENT BIOPSY GUN AND TWO CORES WERE IMMEDIATELY OBTAINED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO REPORTED PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479236 ↗
• InjuryAug 14, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES, DURING USE, THE WIRE BROKE AND CAME APART INSIDE THE PATIENT. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810242 ↗