Closed Wound Suction 0071200Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741049637), received between Apr 19, 2017 and Aug 12, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT WHEN THE EVACUATOR WAS CONNECTED TO THE PANCREATIC SECTION. ALTHOUGH THERE WAS NEGATIVE PRESSURE, WASTE FLUID COULD NOT BE DRAWN. AFTER REPLACING IT WITH A NEW ONE, THE OUTFLOW OF WASTE FLUID WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22785303 ↗
• MalfunctionSep 19, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND INSIDE THE PACKAGING OF THE SUCTION EVACUATOR PRIOR TO OPENING IT IN THE OPERATING ROOM TO DRAIN WASTE FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256032 ↗
• MalfunctionMar 24, 2023Decrease in Suction; Decrease in Pressure; Decrease in Suction; Decrease in Pressure

  IT WAS REPORTED THAT THERE WAS INCORRECT SUCTION PRESSURE AND SUCTION FINISHED QUICKLY. IT TOOK 20 MINUTES TO FULLY INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610476 ↗
• MalfunctionDec 15, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE OUTER BOX WAS FINE, BUT ONE OF THE THREE SMALL BOXES INSIDE WAS CRUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986488 ↗
• MalfunctionDec 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DRAINAGE FLUID LEAKED FROM THE CONNECTION BETWEEN DRAIN AND SUCTION EVACUATOR. THE USER FELT LIKE AIR WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915563 ↗
• MalfunctionMay 20, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT THERE WAS NO SUCTION IN THE SILICONE BULB EVACUATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461857 ↗
• MalfunctionMar 25, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE NEGATIVE PRESSURE COULD NOT BE APPLIED IN THE SILICON BULB EVACUATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904669 ↗
• MalfunctionJul 29, 2020Output Problem; Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE DRAIN TUBE WAS CONNECTED TO THE EVACUATOR THAT WAS CLOSED AND WAS UNABLE TO BE DRAINED. IT WAS HARD TO DISTINGUISH BETWEEN THE EVACUATOR THAT WAS CLOSED AND THE ONE THAT WAS OPEN.

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

  MAUDE report 10338230 ↗
• MalfunctionApr 27, 2020Suction Failure; Therapeutic or Diagnostic Output Failure; Suction Failure

  IT WAS REPORTED THAT IT WAS DIFFICULT TO APPLY THE NEGATIVE PRESSURE.

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

  MAUDE report 10002011 ↗
• MalfunctionMar 23, 2020Disconnection; Detachment of Device or Device Component; Disconnection

  IT WAS REPORTED THAT THE CAP CAME OFF.

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

  MAUDE report 9866336 ↗
• MalfunctionFeb 10, 2020Disconnection; Therapeutic or Diagnostic Output Failure; Disconnection

  IT WAS REPORTED THAT THE CHECK VALVE FELL OUT DURING USE ON THE NEXT DAY OF PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 28 JANUARY 2020, THE "CHECK VALVE" THE COMPLAINANT REFERRED TO WAS THE VALVE INSIDE THE SUCTION EVACUATOR.

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

  MAUDE report 9688579 ↗
• MalfunctionNov 12, 2019Suction Problem; Suction Problem; Suction Failure

  IT WAS REPORTED THAT THE SUCTION DEVICE COULD NOT ASPIRATE DURING USE.

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

  MAUDE report 9309995 ↗
• MalfunctionNov 29, 2018Suction Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO SUCTION DURING PRETEST.

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

  MAUDE report 8118538 ↗
• MalfunctionJul 11, 2017Break

  IT WAS REPORTED THAT THE RING OF THE UPPER PART OF THE SUCTION DEVICE WAS BROKEN ON THE THIRD DAY AFTER PLACEMENT . A LIMITED PROCEDURE DELAY OCCURRED. THE SUCTION EVACUATOR WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6703603 ↗
• MalfunctionApr 19, 2017Detachment Of Device Component; Aspiration Issue

  IT WAS REPORTED THAT THE CAP OF THE DRAINAGE PORT CAME OFF DURING USE, AND THE SUCTION EVACUATOR COULD NOT ASPIRATE. THE DEVICE WAS LATER REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6505578 ↗