IV3000 12X9CM CARTON OF 50 66004009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05000223455255), received between Jan 8, 2021 and Jun 13, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE, MILD ERYTHEMA WAS OBSERVED AROUND THE CATHETER ORIFICE DUE TO ALLERGY; THE SAME IV3000 PORTED 12X9CM CTN 50 WAS CHANGED, RESULTING IN IMPROVEMENT AFTER MEDICAL TREATMENT WITH ORAL ANTIBIOTICS AND TOPICAL CREAM. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT SURGICAL DELAY USING A S+N BACK-UP DEVICE AND NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Erythema

  MAUDE report 22204695 ↗
• MalfunctionMar 29, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED, THAT DURING SET-UP FOR WOUND TREATMENT, IT WAS CONFIRMED SEALING INTEGRITY OF TEN (10) POUCHES IN THE IV3000 PORTED 12X9CM CTN 50 WERE COMPROMISED. A BACKUP WAS AVAILABLE. NO INJURY OR OTHER COMPLICATIONS WERE REPORTED. AS THIS HAPPENED BEFORE TREATMENT. PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635024 ↗
• MalfunctionDec 6, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT, DURING THE ROUTINELY DRESSING CHANGED FOR PATIENTS, A NEW IV3000 SHAPED 12X9CM CTN 50 WAS OPENED AND THE DRESSING WAS SO ADHESIVE THAT BECAME A MASS. TREATMENT WAS RESUMED, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. IT WAS CONFIRMED THAT THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12941588 ↗
• MalfunctionMay 5, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT OCCASIONALLY DURING USE, THE DRESSINGS OF THE IV3000 9CM X 12CM CENTRAL/JUGULAR CATHETERS CTN 50 WOULD NOT STICK TO THE WOUND, AS IF THEY HAD NO FILM. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780378 ↗
• MalfunctionJan 8, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT WHEN PLACING THE IV3000 DRESSING FILM ON THE SKIN, IT DID NOT ADHERE, IT CAME OFF. NO DAMAGE CAUSED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY REPORTED. PATIENT'S CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140167 ↗