Channel Drain 072234Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741049927), received between Sep 6, 2018 and Sep 4, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE COMPLAINT WAS THAT SILICONE CHANNEL DRAIN SHORTER THAN BEFORE. PART NUMBER 072234: ROUND HUBLESS FULL FLUTED SILICONE CHANNEL DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965811 ↗
• MalfunctionOct 24, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE 24 FRENCH INTRALUMEN WAS NOT AS LARGE AS WHAT IT SHOULD BE. THIS WAS A NEW LOT NUMBER THAT THEIR SECTION CATHETERS WOULD NOT FIT IN. THEIR OLD 24 FRENCH WORKED JUST FINE. THIS WAS A NEW LOT THAT CAUSED ISSUES. THEY NEED TO SUCK OUT THE CHEST TUBES WITH THE NG TUBE, UNFORTUNATELY NOW THE INTRO LUMEN OF 24 BLAKE WERE THICKER THAN THEY USED TO BE AND NOT ALLOWING THE SUCTION CATHETER TO PASS THROUGH. IT APPEARED THAT THEY TRULY WERE NOT 24 FRENCH AS DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523380 ↗
• MalfunctionJun 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE STATUS POST STERNOTOMY, CORONARY ARTERY BYPASS GRAFTING X2, A PLEURAL EFFUSION WAS DRAINED ON THE RIGHT CHEST AND 2 24 FR MEDIASTINAL BLAKES WERE PLACED ANTERIOR AND POSTERIOR. ON ARRIVAL FROM OR TO ICU, INTENSIVE CARE UNIT REGISTERED NURSE (ICU RN) NOTED THE LEAK IN ONE OF THE TWO DRAINS, THEY THOUGHT IT WAS THE BULB, REPLACED THE BULB, LEAK CONTINUED SURGEON WAS MADE AWARE AND EXCHANGED THE CHANNEL TUBING, SMALL CRACK FOUND IN TUBING. NO HARM TO PATIENT FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510272 ↗
• MalfunctionMay 24, 2024

  STATUS POST STERNOTOMY, CORONARY ARTERY BYPASS GRAFTING X2, A PLEURAL EFFUSION WAS DRAINED ON THE RIGHT CHEST AND 2 24 FR MEDIASTINAL BLAKES WERE PLACED ANTERIOR AND POSTERIOR. ON ARRIVAL FROM OR TO ICU, INTESIVE CARE UNIT REGSITERED NURSE (ICU RN) NOTED THE LEAK IN ONE OF THE TWO DRAINS, RN THOUGHT IT WAS THE BULB, REPLACED THE BULB, LEAK CONTINUED SURGEON AWARE AND EXCHANGED THE CHANNEL TUBING, SMALL CRACK FOUND IN TUBING. NO HARM TO PATIENT FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391314 ↗
• MalfunctionMay 10, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE INNER ORIFICE OF THESE TUBES CHANGING FREQUENTLY. ALSO REPORTED THAT INCONSISTENT DIAMETERS WITH INNER TUBING SIZES THAT VARIED WITH LOT NUMBERS RESULTING IN DIFFICULTY SUCTIONING. PER FOLLOW UP VIA EMAIL ON 24MAY2024, IT WAS REPORTED THAT THE PHYSICAL SAMPLE WAS STILL AVAILABLE. THE PRODUCT WAS OPENED ONTO THE FIELD, BUT NOT USED FOR THE PATIENT WHEN NOTICED. NO PATIENT HARM WAS REPORTED DURING THE EVENT, BUT CAN BE A POTENTIAL PATIENT HARM IF THEY COULD NOT DRAIN CHEST APPROPRIATELY DUE TO THE DIAMETER OF INNER TUBE BEING SMALLER. IT APPEARED TO BE ONLY CERTAIN LOT NUMBERS. THEY HAD SAVED SOME OF THE DEFECTIVE DRAINS. NO ADDITIONAL LOT NUMBERS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285349 ↗
• MalfunctionJul 15, 2020Material Deformation; Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE DRAIN TUBE WAS TOO ROLLED UP TO USE. PER ADDITIONAL RECEIVED VIA EMAIL ON 30 JUN 2020 FROM IBC REPRESENTATIVE, THERE WAS NO VISIBLE DEFECT AND PHOTO SAMPLES WERE ATTACHED.

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

  MAUDE report 10275480 ↗
• MalfunctionMar 6, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS HAIR IN THE PACKAGE OF THE WOUND DRAIN.

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

  MAUDE report 9800834 ↗
• MalfunctionFeb 25, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A HAIR FOUND IN THE PACKAGE OF THE WOUND DRAIN.

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

  MAUDE report 9750663 ↗
• MalfunctionApr 3, 2019Collapse

  IT WAS REPORTED THAT THE SILICONE CHANNEL DRAIN COLLAPSED DURING USE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

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

  MAUDE report 8479907 ↗
• MalfunctionSep 6, 2018Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT DURING SURGERY, THE CHANNEL DRAIN WAS FLIMSY AND CONTINUED TO COLLAPSE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 7850140 ↗