Channel Drain V072228Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741119163), received between Oct 8, 2024 and Nov 7, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE WOUND DRAINS ARE TOO COMPRESSIBLE AND STOP WORKING. THEY HAVE BROKEN OFF IN PATIENTS, AND THEY HAVE CAUSED SEROMAS IN PATIENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Seroma

  MAUDE report 23496071 ↗
• MalfunctionNov 6, 2025Material Too Soft/Flexible; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE WOUND DRAINS ARE TOO COMPRESSIBLE AND STOP WORKING. THEY HAVE BROKEN OFF IN PATIENTS, AND THEY HAVE CAUSED SEROMAS IN PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488048 ↗
• MalfunctionNov 6, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE WOUND DRAINS ARE TOO COMPRESSIBLE AND STOP WORKING. THEY HAVE BROKEN OFF IN PATIENTS, AND THEY HAVE CAUSED SEROMAS IN PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488039 ↗
• MalfunctionOct 14, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT WHEN CUSTOMER TRIALED THE WOULD DRAINS, THEY SEEMED SUBSTANTIALLY EQUIVALENT TO THEIR CURRENT DRAINS AND PERHAPS EVEN BETTER DUE TO THEIR SOFTER SILICONE. HOWEVER, THEY HAD NOTICED A PATTERN OF CONCERNING FINDINGS WHICH HAS LED THEM TO BELIEVE THEY NEED TO SWITCH BACK TO THEIR OLD VENDOR AS SOON AS POSSIBLE. SPECIFICALLY, CUSTOMER HAD ONE DRAIN BROKE OFF IN A PATIENT NECESSITATING OPERATIVE EXPLORATION, THE DRAINS ROUTINELY FAIL TO MAINTAIN SUCTION, INCREASED THE RISK FOR SEROMA AND INFECTION AND THEY OFTEN BECOME DISCONNECTED FROM THE BULB RESERVOIR, WHICH WAS MADE BY A DIFFERENT MANUFACTURER. CUSTOMER USED HUNDREDS OF DRAINS PER YEAR AND THEIR PERFORMANCE WAS CRITICAL TO THE SUCCESS OF THEIR PROCEDURES. CUSTOMER BELIEVED THAT THEIR CURRENT DRAINS WERE POSING A SIGNIFICANT ONGOING THREAT TO THE WELL-BEING OF THEIR PATIENTS. PER ADDITIONAL INFORMATION RECEIVED ON 27SEP2024, IT WAS REPORTED THAT THE NOVAPLUS 10 FR CHANNEL DRAIN WAS CLINICALLY UNACCEPTABLE BECAUSE TWICE IT HAD BROKEN OFF AT THE SKIN WHEN THEY INSERTED THE DRAIN. THIS INCIDENT OCCURRED AT THE (B)(6) HOSPITAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440287 ↗
• InjuryOct 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN CUSTOMER TRIALED THE WOULD DRAINS, THEY SEEMED SUBSTANTIALLY EQUIVALENT TO THEIR CURRENT DRAINS AND PERHAPS EVEN BETTER DUE TO THEIR SOFTER SILICONE. HOWEVER, THEY HAD NOTICED A PATTERN OF CONCERNING FINDINGS WHICH HAS LED THEM TO BELIEVE THEY NEED TO SWITCH BACK TO THEIR OLD VENDOR AS SOON AS POSSIBLE. SPECIFICALLY, CUSTOMER HAD ONE DRAIN BROKE OFF IN A PATIENT NECESSITATING OPERATIVE EXPLORATION, THE DRAINS ROUTINELY FAIL TO MAINTAIN SUCTION, INCREASED THE RISK FOR SEROMA AND INFECTION AND THEY OFTEN BECOME DISCONNECTED FROM THE BULB RESERVOIR, WHICH WAS MADE BY A DIFFERENT MANUFACTURER. CUSTOMER USED HUNDREDS OF DRAINS PER YEAR AND THEIR PERFORMANCE WAS CRITICAL TO THE SUCCESS OF THEIR PROCEDURES. CUSTOMER BELIEVED THAT THEIR CURRENT DRAINS WERE POSING A SIGNIFICANT ONGOING THREAT TO THE WELL-BEING OF THEIR PATIENTS. PER ADDITIONAL INFORMATION RECEIVED ON 27SEP2024, IT WAS REPORTED THAT THE NOVAPLUS 10 FR CHANNEL DRAIN WAS CLINICALLY UNACCEPTABLE BECAUSE TWICE IT HAD BROKEN OFF AT THE SKIN WHEN THEY INSERTED THE DRAIN. THIS INCIDENT OCCURRED AT THE SKOKIE HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20398103 ↗