Achieve® 10884450443948Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884450443948), received between Sep 29, 2022 and Sep 10, 2026 — classified as 1 injury, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Failure to Obtain Sample

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50720157 ↗
• MalfunctionMay 21, 2026Failure to Obtain Sample

  IT WAS REPORTED THAT DURING MICRO-GUIDED BIOPSY, NO TISSUE CORE WAS FOUND IN THE SAMPLING SLOT AFTER THE NEEDLE WAS WITHDRAWN FROM THE PATIENT. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY, MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246218 ↗
• 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 24378123 ↗
• InjurySep 29, 2022Material Twisted/Bent; Material Twisted/Bent

  THE ACCOUNT ALLEGES THAT DURING A PROSTATE BIOPSY PROCEDURE, THE NEEDLE BENT INTERNALLY WHICH RESULTED IN HEMORRHAGING WITHIN THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15507024 ↗