Channel Drain 072223Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741049842), received between Apr 10, 2017 and Aug 27, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Failure to Capture

  It was reported that after a kidney transplant, a drain was placed in the donor patient after surgery. The drain doesn't show up on the X ray and wanted to check if there was something wrong with the product. As usual, took the images with the Fujifilm Carneo GO Plus. The patient was a 75 year old woman and not obese. The device was still in place. Typically, a postoperative drainage tube would be visible in the image. Health professional plan to retrieve the device later if possible; for now, need to investigate whether any similar incidents have occurred with this specific lot.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482356 ↗
• MalfunctionFeb 25, 2026Flaked

  IT WAS REPORTED THAT THE 3 MORE WOUND DRAIN THAT A DOCTOR HAD USED WERE FLAKING. LOT: NGKW1644, NGKX2316.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444451 ↗
• MalfunctionFeb 23, 2026Failure to Capture

  IT WAS REPORTED THAT THE IMAGE QUALITY WAS POOR BEFORE USE, DESPITE THE PRESENCE OF AN X-RAY OPAQUE LINE. FOR BATCH NO. NGKS3120, NGKT2584, AND FOR NGKU1447 BATCH NO. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 18FEB2026, STATED THAT MULTIPLE INSTANCES OCCURRED WHERE POOR IMAGING WAS OBSERVED DURING PATIENT USE OF THIS PRODUCT, DESPITE THE PRESENCE OF RADIOPAQUE LINES EXACT OCCURRENCE DATES AND SPECIFIC QUANTITIES UNKNOWN. ADDITIONALLY, POOR IMAGING WAS OBSERVED IN SEVERAL PRODUCTS NOT ONLY IN UROLOGY BUT ALSO IN OTHER DEPARTMENTS SURGERY. THEREFORE, SINCE THERE WAS NO TRUST IN THE CURRENT HOSPITAL INVENTORY OF THIS LOT, REQUEST A RECALL AND INVESTIGATION OF ALL UNITS. FOR THE 3 LOTS (13 UNITS) BEING RETURNED THIS TIME, IT IS UNKNOWN WHETHER THEY ARE THE ACTUAL UNITS WHERE THE APPROPRIATE ACTION WAS TAKEN. LOT: NGKS3120, NGKT2584, NGKU1447.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422260 ↗
• MalfunctionFeb 23, 2026Failure to Capture

  IT WAS REPORTED THAT THE IMAGE QUALITY WAS POOR BEFORE USE, DESPITE THE PRESENCE OF AN X-RAY OPAQUE LINE. FOR BATCH NO. NGKS3120, NGKT2584, AND FOR NGKU1447 BATCH NO. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 18FEB2026, STATED THAT MULTIPLE INSTANCES OCCURRED WHERE POOR IMAGING WAS OBSERVED DURING PATIENT USE OF THIS PRODUCT, DESPITE THE PRESENCE OF RADIOPAQUE LINES EXACT OCCURRENCE DATES AND SPECIFIC QUANTITIES UNKNOWN. ADDITIONALLY, POOR IMAGING WAS OBSERVED IN SEVERAL PRODUCTS NOT ONLY IN UROLOGY BUT ALSO IN OTHER DEPARTMENTS SURGERY. THEREFORE, SINCE THERE WAS NO TRUST IN THE CURRENT HOSPITAL INVENTORY OF THIS LOT, REQUEST A RECALL AND INVESTIGATION OF ALL UNITS. FOR THE 3 LOTS ((B)(4) UNITS) BEING RETURNED THIS TIME, IT IS UNKNOWN WHETHER THEY ARE THE ACTUAL UNITS WHERE THE APPROPRIATE ACTION WAS TAKEN. LOT: NGKS3120, NGKT2584, NGKU1447.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422022 ↗
• MalfunctionFeb 23, 2026Failure to Capture

  IT WAS REPORTED THAT THE IMAGE QUALITY WAS POOR BEFORE USE, DESPITE THE PRESENCE OF AN X-RAY OPAQUE LINE. FOR BATCH NO. NGKS3120, NGKT2584, AND FOR NGKU1447 BATCH NO. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 18 FEB 2026, STATED THAT MULTIPLE INSTANCES OCCURRED WHERE POOR IMAGING WAS OBSERVED DURING PATIENT USE OF THIS PRODUCT, DESPITE THE PRESENCE OF RADIOPAQUE LINES EXACT OCCURRENCE DATES AND SPECIFIC QUANTITIES UNKNOWN. ADDITIONALLY, POOR IMAGING WAS OBSERVED IN SEVERAL PRODUCTS NOT ONLY IN UROLOGY BUT ALSO IN OTHER DEPARTMENTS SURGERY. THEREFORE, SINCE THERE WAS NO TRUST IN THE CURRENT HOSPITAL INVENTORY OF THIS LOT, REQUEST A RECALL AND INVESTIGATION OF ALL UNITS. FOR THE 3 LOTS (13 UNITS) BEING RETURNED THIS TIME, IT IS UNKNOWN WHETHER THEY ARE THE ACTUAL UNITS WHERE THE APPROPRIATE ACTION WAS TAKEN. LOT: NGKS3120, NGKT2584, NGKU1447.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422019 ↗
• MalfunctionJan 30, 2026Failure to Capture; Erratic or Intermittent Display

  IT WAS REPORTED THAT WHILE USING THE WOUND DRAIN, THE IMAGE QUALITY WAS POOR EVEN THOUGH THERE WAS AN X-RAY OPAQUE LINE. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 23JAN2026, STATED THAT NUMBER OF INCIDENTS WAS 5 AND QUANTITY OF RETURNED ITEM IS 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223856 ↗
• MalfunctionDec 19, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE TROCAR WAS NOT SHARP ENOUGH AND THEY DO NOT LIKE THE HUB ON THE DRAIN. PROVIDED THEM WITH A HUBLESS DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854399 ↗
• MalfunctionFeb 14, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THESE NEW WOUND DRAIN THAT THEY HAVE DID NOT SEEM TO BE AS SHARP AS THE PREVIOUS BRAND. TO THE POINT THAT IT WOULD NOT BE A STRETCH TO THINK THAT IT WAS A MATTER OF TIME BEFORE SOMEONE STABS THEMSELVES TRYING TO GET THEM THROUGH THE SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384473 ↗
• MalfunctionJun 10, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CHANNEL DRAIN WAS USED IN THE OPERATING ROOM OF BREAST SURGERY ON (B)(6). A DRAIN WAS PLACED, BUT NOT A SINGLE DROP OF FLUID WAS FLOWING. THE DRAIN LUMEN WAS CLOGGED. THE PRODUCT HAS BEEN DISCARDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499037 ↗
• MalfunctionJul 17, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS BLACK MARK ON THE DRAIN TUBE WHERE THERE WOULD NORMALLY BE NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332480 ↗
• InjuryNov 3, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT HAD A DRAIN. UPON REMOVAL, THE DEVICE SNAPPED AND BROKE OFF AT THE RIGHT WHERE IT ENTERED THE PATIENT. A PROCEDURE WAS UNDERTAKEN TO REMOVE THE BROKEN PIECE OF THE DEVICE, WHICH OCCURRED ABOUT TWO AND A HALF WEEKS AGO. THERE WAS NO IMAGING, BUT A BROKEN PORTION OF THE DEVICE WAS REMOVED THROUGH AN INCISION.

  Patient problems: Foreign Body In Patient

  MAUDE report 15722762 ↗
• MalfunctionJan 4, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE CHANNEL DRAIN WAS UNABLE TO SUCTION. IT WAS STATED THAT THERE WAS NO PROBLEM WITH THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158576 ↗
• MalfunctionJun 4, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE DRAINAGE WAS UNABLE TO SUCTION. WHEN THE DEVICE WAS REMOVED, THE DRAINAGE HAD STOPPED IN THE MIDDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938563 ↗
• MalfunctionApr 7, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL LIKE HAIR WAS FOUND WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628653 ↗
• MalfunctionFeb 15, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN HAD A ¿HUB¿ THAT WAS WIDER IN DIAMETER THAN THE REST OF THE DRAIN AND RESULTED WITH DRAINING ISSUES. EXPLAINED AND SUGGESTED THE ALTERNATE BARD PRODUCT TO THE SURGEON AS BARD DID NOT HAVE ANY HUB LESS DRAINS THAT ARE 3/4 FLUTED, BUT SOME DID HAVE SOME HUB LESS, FULL-FLUTED OPTIONS. BUT THE SURGEON WAS AGAINST USING THE DRAINS AND DID NOT WANT TO SWITCH TO ANYTHING WHICH WAS USING LAST 2 DECADES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11326671 ↗
• MalfunctionJun 26, 2019Restricted Flow rate; Restricted Flow rate; No Flow

  IT WAS REPORTED THAT THE CHANNEL DRAIN DRAINAGE WAS STOPPED.

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

  MAUDE report 8734799 ↗
• MalfunctionJan 4, 2019Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem

  IT WAS REPORTED THAT THE CHANNEL DRAIN WAS UNABLE TO DRAIN DURING SURGERY. THE CHANNEL DRAIN WAS REPLACED.

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

  MAUDE report 8217766 ↗
• MalfunctionJan 3, 2019Restricted Flow rate; Suction Problem; Restricted Flow rate

  IT WAS REPORTED THAT THE CHANNEL DRAIN WAS UNABLE TO DRAIN DURING SURGERY. THE CHANNEL DRAIN WAS REPLACED.

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

  MAUDE report 8213608 ↗
• MalfunctionNov 29, 2018Suction Problem; Suction Problem

  IT WAS REPORTED THAT THE CHANNEL DRAIN WAS UNABLE TO SUCTION. ANOTHER ONE WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118485 ↗
• MalfunctionOct 25, 2018Use of Device Problem; Use of Device Problem; Suction Failure

  IT WAS REPORTED THAT IT WAS DIFFICULT TO SUCTION FROM THE DRAIN. THE DRAIN DID NOT SUCTION DURING THE SURGERY, SO THE DOCTOR OPENED THE WOUND AND REPLACED WITH A NEW DRAIN.

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

  MAUDE report 8004378 ↗
• MalfunctionSep 27, 2018Partial Blockage; Restricted Flow rate; No Flow; Partial Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE CHANNEL DRAIN HAD DIFFICULTY DRAINING.

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

  MAUDE report 7914861 ↗
• MalfunctionMar 24, 2018Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS DAMAGE FOUND ON THE DRAIN TUBE WHEN HE/SHE OPENED THE PACKAGE. THE DEVICE WAS NOT USED. PER SAMPLE EVALUATION, THE FOREIGN MATERIAL WAS FOUND ON THE OUTSIDE OF THE DEVICE, INSIDE THE CLOSED PACKAGE.

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

  MAUDE report 7368590 ↗
• MalfunctionJan 16, 2018Device Contamination With Biological Material; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND ON THE DEVICE. UPON IN-HOUSE INSPECTION, A HAIR WAS ATTACHED ON THE DRAIN TUBE.

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

  MAUDE report 7194316 ↗
• MalfunctionNov 22, 2017Break

  IT WAS REPORTED THAT THERE WAS DAMAGE FOUND ON THE DRAIN TUBE WHEN HE/SHE OPENED THE PACKAGE. THE DEVICE WAS NOT USED.

  Patient problems: No Patient Involvement

  MAUDE report 7054046 ↗
• MalfunctionJul 18, 2017Aspiration Issue

  IT WAS REPORTED THAT BODY FLUID WAS NOT ASPIRATED. THE DRAIN TUBE WAS CONNECTED TO THE SUCTION DEVICE, AND NEGATIVE PRESSURE WAS APPLIED. THERE WAS NO PATIENT INJURY REPORTED AND A LIMITED PROCEDURE DELAY OCCURRED. THE SUCTION EVACUATOR WAS REPLACED AND THE TREATMENT WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723496 ↗