IV3000 FRAME 10CMX12CM CE CTN OF 50 59410882Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00040565120607), received between May 6, 2021 and Jul 21, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2021Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem

  IT WAS REPORTED THAT, DURING SET UP FOR IV THERAPY, WHEN REMOVING THE BACKING PAPER OF TWO (2) IV3000 10CM X 12CM CENTRAL LINE CATHETERS DRESSINGS, IT WAS NOTICED THAT THERE WERE DAMAGES ARRAYED IN LINEAR DISPOSITION, FOLLOWING THE DRESSING PATTERN, WITH A SMALL HOLE ON THE SURFACES. THE IV THERAPY WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203231 ↗
• MalfunctionMay 6, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING TREATMENT, IT WAS DISCOVERED THAT THE CORNER OF 20 IV3000 10CM X 12CM CENTRAL LINE CATHETERS CTN 50 PEELED OF EASILY AND IT WAS DIFFICULT TO DETACH THE DRESSING FROM THE PAPER COVER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787967 ↗
• MalfunctionMay 6, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING TREATMENT, IT WAS DISCOVERED THAT THE CORNER OF 20 IV3000 10CM X 12CM CENTRAL LINE CATHETERS CTN 50 PEELED OF EASILY AND IT WAS DIFFICULT TO DETACH THE DRESSING FROM THE PAPER COVER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787884 ↗
• MalfunctionMay 6, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING TREATMENT, IT WAS DISCOVERED THAT THE CORNER OF 20 IV3000 10CM X 12CM CENTRAL LINE CATHETERS CTN 50 PEELED OF EASILY AND IT WAS DIFFICULT TO DETACH THE DRESSING FROM THE PAPER COVER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787875 ↗