AutoMate® 663100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI D0026631001), received between Feb 14, 2023 and Mar 10, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Break; Break

  IN THIS EVENT IT IS REPORTED THAT A AUTOMATE TOOL REFILL BROKE DURING USE. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559093 ↗
• MalfunctionAug 22, 2024Break; Break

  IN THIS EVENT IT IS REPORTED THAT AUTOMATE TOOL REFILL BROKE DURING USE. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025406 ↗
• MalfunctionJun 7, 2023Break; Break

  IN THIS EVENT IT IS REPORTED THAT A AUTOMATE TOOL REFILL BROKE DURING USE. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078187 ↗
• MalfunctionMar 23, 2023Break; Break

  IN THIS EVENT IT IS REPORTED THAT A AUTOMATE TOOL REFILL BROKE DURING USE. REPORTEDLY, NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16599461 ↗
• MalfunctionFeb 14, 2023Break; Break

  IN THIS EVENT IT IS REPORTED THAT AUTOMATE TOOL BROKE DURING USE. OUTCOME IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION IS PENDING.

  Patient problems: Insufficient Information

  MAUDE report 16371643 ↗