Channel Drain 072190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741049729), received between Jan 20, 2020 and Aug 19, 2025 — classified as 4 injuries, 6 malfunctions.

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

• MalfunctionAug 19, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THEY HAVE RECEIVED ADDITIONAL COMPLAINTS WITH THAT WOUND DRAIN, AS WELL AS IDENTIFIED THAT THIS MAY AFFECT MULTIPLE ITEMS NOT JUST THE ORIGINALLY REPORTED 072221. THEY NEED TO SET UP A CALL, TO DISCUSS OVER THAT ISSUE. THEY WERE LOOKING AT REMOVING THAT PRODUCT AND OTHERS FROM INVENTORY TILL THEY HAVE AN ALL CLEAR. THEY MENTIONED IMPACTED MATERIAL BELOW: MATERIAL#: 072211, MATERIAL#: 072190, MATERIAL#: 072189, MATERIAL#: 072214, MATERIAL#: 072186. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 14AUG2025, CUSTOMER INSPECTED SIMILAR ITEMS AT THEIR DISTRIBUTION CENTER AND FOUND FUZZY HAIR FOREIGN MATTER IN THOSE ITEMS AS WELL. NO HARM TO A PATIENT AS THESE WERE FOUND BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840482 ↗
• MalfunctionMay 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE HAIR FOUND IN WOUND DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950241 ↗
• MalfunctionFeb 18, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SURGEON HAD A PATIENT UNDERGOING MASTECTOMY AND AXILLARY DISSECTION, PLACED A WOUND DRAIN, AND THEN UPON REMOVAL (WHICH WAS VERY DIFFICULT) NOTED THAT THE DRAIN HAD TIED UPON ITSELF, NECESSITATING QUITE A BIT OF FINESSE FOR REMOVAL, AND A LARGER EXIT POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392218 ↗
• MalfunctionApr 17, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE WOUND DRAINS WERE NOT HOLDING SUCTION AND SEEMED TO BE TAKING ON AIR. THEY AFFECTED LOTS WERE LOT# NGHY3059, LOT#NGHV1449 AND LOT#NGHQ2162.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124326 ↗
• InjuryMar 19, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT UPON REMOVAL OF WOUND DRAIN THE TIP OF IT REMAINED IN THE CAVITY. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18929013 ↗
• InjuryDec 20, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SILICON DRAIN WAS BROKE OFF DURING ATTEMPTED REMOVAL AND SILICON TIP OF DRAIN WAS RETAINED INSIDE THE PATIENT. THE POSSIBLE LOT# WERE: NGGN2906, NGGZ2612, NGGV0936. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18363545 ↗
• InjuryDec 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SILICON DRAIN WAS BROKE OFF DURING ATTEMPTED REMOVAL AND SILICON TIP OF DRAIN WAS RETAINED INSIDE THE PATIENT. THE POSSIBLE LOT# WERE: NGGN2906, NGGZ2612, NGGV0936. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18345590 ↗
• InjuryDec 18, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SILICON DRAIN WAS BROKE OFF DURING ATTEMPTED REMOVAL AND SILICON TIP OF DRAIN WAS RETAINED INSIDE THE PATIENT. THE POSSIBLE LOT# WERE: NGGN2906, NGGZ2612, NGGV0936. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18345586 ↗
• MalfunctionOct 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PORTION OF A BARD FLUTED DRAIN BROKE OFF AT THE TIME OF REMOVAL WHEN REMOVAL WAS DONE AT THE BEDSIDE. CUSTOMER LEARNED THIS WAS NOT CONSIDERED AN RFO BUT DID NEED TO BE REPORTED TO THE FDA AND THE MANUFACTURER AS A POSSIBLE DEVICE FAILURE. UNFORTUNATELY, CUSTOMER DID NOT KEEP THE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003386 ↗
• MalfunctionJan 20, 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 IN THE CHANNEL DRAIN PACKAGE, AND IT COULD NOT BE USED.

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

  MAUDE report 9606988 ↗