Closed Wound Suction 0070400Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741049491), received between Oct 9, 2018 and May 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT BEFORE USE, NEGATIVE PRESSURE CANNOT BE APPLIED IN SUCTION EVACUATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105983 ↗
• MalfunctionMay 19, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON CHECKING, THE STOPPER OF THE SILICONE BULB EVACUATOR WAS DAMAGED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435540 ↗
• MalfunctionOct 9, 2018Suction Problem

  IT WAS REPORTED THAT THE EVACUATOR WAS DIFFICULT TO SUCTION DURING USE. ANOTHER DEVICE WAS USED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7948298 ↗