Achieve® 10884450443931Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884450443931), received between Aug 5, 2025 and Oct 28, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE DOCTOR PERFORMING A PROSTATE BIOPSY REPORTED THE FIRST BIOPSIES ON ONE SIDE WERE COMPLETED WITHOUT DIFFICULTY, BUT WAS UNABLE TO RESET THE NEEDLE TO PERFORM THE SECOND SIDE. THIS NEEDLE WAS DISCARDED AND 2 MORE NEEDLES WERE UNABLE TO OBTAIN ANY "CORE SAMPLES" (RELOADING WAS POSSIBLE). THE PROCEDURE WAS COMPLETED WITH THE FOURTH NEEDLE FUNCTIONING AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405565 ↗
• MalfunctionAug 5, 2025Failure to Fire; Failure to Fire

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE DID NOT FIRE AND DID NOT COLLECT A SAMPLE. UNDER NORMAL CIRCUMSTANCES, PROVIDERS ARE ABLE TO OBTAIN 2-3 SAMPLES PER DEVICE. HOWEVER, WITH THE AFFECTED LOTS, THEY HAVE CONSISTENTLY FOUND THAT WHILE THE FIRST SAMPLE IS OBTAINED WITHOUT ISSUE, ANY SUBSEQUENT SAMPLES BECOME SHREDDED AND UNUSABLE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720643 ↗
• MalfunctionAug 5, 2025Failure to Fire; Failure to Fire

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE DID NOT FIRE AND DID NOT COLLECT A SAMPLE. UNDER NORMAL CIRCUMSTANCES, PROVIDERS ARE ABLE TO OBTAIN 2-3 SAMPLES PER DEVICE. HOWEVER, WITH THE AFFECTED LOTS, THEY HAVE CONSISTENTLY FOUND THAT WHILE THE FIRST SAMPLE IS OBTAINED WITHOUT ISSUE, ANY SUBSEQUENT SAMPLES BECOME SHREDDED AND UNUSABLE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720642 ↗
• MalfunctionAug 5, 2025Failure to Fire; Failure to Fire

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE DID NOT FIRE AND DID NOT COLLECT A SAMPLE. UNDER NORMAL CIRCUMSTANCES, PROVIDERS ARE ABLE TO OBTAIN 2-3 SAMPLES PER DEVICE. HOWEVER, WITH THE AFFECTED LOTS, THEY HAVE CONSISTENTLY FOUND THAT WHILE THE FIRST SAMPLE IS OBTAINED WITHOUT ISSUE, ANY SUBSEQUENT SAMPLES BECOME SHREDDED AND UNUSABLE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720639 ↗
• MalfunctionAug 5, 2025Failure to Fire; Failure to Fire

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO TAKE BIOPSIES THE BIOPSY DEVICE DID NOT FIRE AND DID NOT COLLECT A SAMPLE. UNDER NORMAL CIRCUMSTANCES, PROVIDERS ARE ABLE TO OBTAIN 2-3 SAMPLES PER DEVICE. HOWEVER, WITH THE AFFECTED LOTS, THEY HAVE CONSISTENTLY FOUND THAT WHILE THE FIRST SAMPLE IS OBTAINED WITHOUT ISSUE, ANY SUBSEQUENT SAMPLES BECOME SHREDDED AND UNUSABLE. NO PATIENT INJURY TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720638 ↗