AML EXCEL 2001-42-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,009 adverse event reports that list this exact device (DI 10603295079941), received between Jun 21, 2017 and Sep 29, 2026 — classified as 4 injuries, 2,005 malfunctions.

The most frequently reported specific device problem is “Break” (1,077 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 25 most recent of 2,009 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937132 ↗
• MalfunctionSep 29, 2026Break

  It was reported that the white T-handle broke in the case.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930634 ↗
• MalfunctionSep 25, 2026Break; Crack

  It was reported during as surgical procedure, it was observed that the white t handle had a visible crack (broken) in the white handle part of the instrument. The instrument was not used during the case and removed from the field.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900345 ↗
• MalfunctionSep 23, 2026Device-Device Incompatibility

  It was reported that the T-handle is not functioning properly. It is very difficult to attach and remove the corkscrew. It did not happen in surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870624 ↗
• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845855 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829075 ↗
• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829071 ↗
• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778641 ↗
• MalfunctionSep 15, 2026Break; Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776231 ↗
• MalfunctionSep 14, 2026No Apparent Adverse Event

  It was reported that all instruments are in need of replacements.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762983 ↗
• MalfunctionSep 14, 2026Break

  It was reported that the t handle broke in two pieces when taking the head out.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758496 ↗
• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754744 ↗
• MalfunctionSep 14, 2026Break

  It was reported that the T-handle was broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50753220 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721730 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716607 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50551072 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549225 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548877 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541921 ↗
• MalfunctionAug 31, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531973 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50450922 ↗
• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410416 ↗
• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410065 ↗
• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409678 ↗
• MalfunctionAug 24, 2026Break

  It was reported that the EXCEL T-Handle devices had wear and tear from multiple uses and the handles were cracked/broken and could not be re-used. It was reported that some devices are cracked at the handle, and two of them are broken in two pieces or more. It was reported that no fragments were generated. There was no patient or user harm reported, and no significant surgical delay. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409279 ↗