Closed Wound Suction V0070740Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741051609), received between Oct 5, 2017 and Jan 12, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Disconnection; Material Fragmentation

  IT WAS REPORTED THAT EXTERNAL PORTION OF THE EVACUATOR TUBING WAS SNAPPED. IT SOUNDED LIKE THIS OCCURRED DURING THE USE OF THE PRODUCT, BUT THAT WASN'T CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032145 ↗
• MalfunctionOct 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER PULLED THE WOUND SUCTION JP BULB OFF OF THE SHELF (SINGLE STERILE). THE CIF FILED FOR THE PACK WHERE THE HAIR WAS FOUND ON THE MAYO TRAY IS CORRECT AND CAN BE SUBMITTED. BUT THEY WOULD NEED A CIF FILED FOR THE JP BULB WHERE A HAIR WAS FOUND WHEN OPENED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025, THE DEFECT WAS NOTICED PRIOR TO USE. PATIENT WAS NOT IN THE ROOM AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301082 ↗
• MalfunctionOct 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER PULLED THE WOUND SUCTION JP BULB OFF OF THE SHELF (SINGLE STERILE). THE CIF FILED FOR THE PACK WHERE THE HAIR WAS FOUND ON THE MAYO TRAY IS CORRECT AND CAN BE SUBMITTED. BUT THEY WOULD NEED A CIF FILED FOR THE JP BULB WHERE A HAIR WAS FOUND WHEN OPENED. PER ADDITIONAL INFORMATION RECEIVED ON 09DEC2025, THE DEFECT WAS NOTICED PRIOR TO USE. PATIENT WAS NOT IN THE ROOM AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278137 ↗
• MalfunctionNov 7, 2022Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE EVACUATOR BULB SUCTIONING FOR THE WOUND RECEIVED SIX WRONG LABELS. STATED THAT SIX 400ML EVACUATOR RECEIVED THEM AS A WRONG LABEL. THE AFFECTED EVACUATORS WERE (PCN# V0070740) AND (PCN# V0043610).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748506 ↗
• MalfunctionSep 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CUSTOMER RECEIVED THE 1 CASE OF SILICONE EVACUATOR AS DAMAGED DUE TO SOILED AND DRY-WET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501061 ↗
• MalfunctionJul 29, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT SILICON EVACUATOR OUTLET TUBE WAS SLIGHTLY LARGE MAKING IT LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12249316 ↗
• MalfunctionOct 5, 2017Device Contamination With Biological Material

  IT WAS REPORTED THAT HAIR WAS FOUND INSIDE OF THE DEVICE.

  Patient problems: No Information

  MAUDE report 6919210 ↗