NA 356.301Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982195319), received between Jun 17, 2024 and Jun 17, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON MAY 22, 2024 SIX DEVICES HAD CRACKS OR BREAKAGES ON THE Y-CONNECTOR AFTER AUTOCLAVE STERILIZATION. THE BREAK OR CRACK APPEARED IN THE MIDDLE OF THE Y. THERE WAS NO PATIENT INJURY. THIS REPORT IS FOR A 50 DEG TAMP. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19552971 ↗
• MalfunctionJun 17, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2024 SIX DEVICES HAD CRACKS OR BREAKAGES ON THE Y-CONNECTOR AFTER AUTOCLAVE STERILIZATION. THE BREAK OR CRACK APPEARED IN THE MIDDLE OF THE Y. THERE WAS NO PATIENT INJURY. THIS REPORT IS FOR A 50 DEG TAMP. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19552130 ↗
• MalfunctionJun 17, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2024 SIX DEVICES HAD CRACKS OR BREAKAGES ON THE Y-CONNECTOR AFTER AUTOCLAVE STERILIZATION. THE BREAK OR CRACK APPEARED IN THE MIDDLE OF THE Y. THERE WAS NO PATIENT INJURY. THIS REPORT IS FOR A 50 DEG TAMP. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19552128 ↗
• MalfunctionJun 17, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2024 SIX DEVICES HAD CRACKS OR BREAKAGES ON THE Y-CONNECTOR AFTER AUTOCLAVE STERILIZATION. THE BREAK OR CRACK APPEARED IN THE MIDDLE OF THE Y. THERE WAS NO PATIENT INJURY. THIS REPORT IS FOR A 50 DEG TAMP. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19552090 ↗
• MalfunctionJun 17, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2024 SIX DEVICES HAD CRACKS OR BREAKAGES ON THE Y-CONNECTOR AFTER AUTOCLAVE STERILIZATION. THE BREAK OR CRACK APPEARED IN THE MIDDLE OF THE Y. THERE WAS NO PATIENT INJURY. THIS REPORT IS FOR A 50 DEG TAMP. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19551974 ↗
• MalfunctionJun 17, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON MAY 22, 2024 SIX DEVICES HAD CRACKS OR BREAKAGES ON THE Y-CONNECTOR AFTER AUTOCLAVE STERILIZATION. THE BREAK OR CRACK APPEARED IN THE MIDDLE OF THE Y. THERE WAS NO PATIENT INJURY. THIS REPORT IS FOR A 50 DEG TAMP. THIS IS REPORT 4 OF 6 FOR (B )(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19551959 ↗