Silicone Round Drain 0070210Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741049439), received between Mar 11, 2019 and May 17, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SPD DEPARTMENT FOUND, UPON PULLING CASES, THAT A FEW OF THE TUBES HAD BLACK DOTS ON THEM (NOT ALL PACKAGES). ADDITIONAL PRODUCTS UNDER ANOTHER REFERENCE NUMBER WERE ALSO NOTED TO HAVE BLACK DOTS ALONG THE TUBING. IT WAS FURTHER REPORTED THAT BOTH REF 070210AND 070310 HAD THESE BLACK DOTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196442 ↗
• InjuryJan 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WOUND DRAIN BROKE INSIDE OF PATIENT. THE PATIENT HAD TO BE BROUGHT TO SURGERY, AND THE DRAIN WAS REMOVED PER DOCTOR UNDER FLUOROSCOPY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18428031 ↗
• MalfunctionDec 2, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A BLUE STRING/FIBER FOUND INSIDE THE PACKAGE OF WOUND DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920475 ↗
• MalfunctionDec 5, 2019Obstruction of Flow; Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT THE DEVICE CLOGGED EASILY AND BECAME DISPLACED.

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

  MAUDE report 9418939 ↗
• InjuryMay 16, 2019Break; Difficult to Remove; Material Deformation; Break

  IT WAS REPORTED THAT WHEN THE DOCTOR ATTEMPTED TO REMOVE THE WOUND DRAIN; IT WAS CLEARLY ANCHORED DUE TO THE TISSUE INGROWTH INTO THE ORIFICES OF THE DRAIN LEADING TO A PORTION OF THE DRAIN BREAKING OFF INSIDE OF THE PATIENT. IT WAS ALSO NOTED THAT THIS HAS OCCURRED THREE TIMES IN A SIX MONTH PERIOD DUE TO THE DRAIN MATERIAL BEING TOO THIN.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8615569 ↗
• InjuryMar 11, 2019Break

  IT WAS REPORTED THAT THE WOUND DRAIN BROKE INSIDE OF THE PATIENT. THE PATIENT UNDERWENT SURGERY TO LOCATE THE DRAIN AS IT HAD AN IN GROWTH OF TISSUE THAT HAD TO BE CUT OUT.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8408074 ↗
• InjuryMar 11, 2019Break

  IT WAS REPORTED THAT THE WOUND DRAIN BROKE INSIDE OF THE PATIENT. THE PATIENT UNDERWENT SURGERY TO LOCATE THE DRAIN AS IT HAD AN IN GROWTH OF TISSUE THAT HAD TO BE CUT OUT.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8408035 ↗
• InjuryMar 11, 2019Break

  IT WAS REPORTED THAT THE WOUND DRAIN BROKE INSIDE OF THE PATIENT. THE PATIENT UNDERWENT SURGERY TO LOCATE THE DRAIN AS IT HAD AN IN GROWTH OF TISSUE THAT HAD TO BE CUT OUT.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8408033 ↗