Omnifix™ 4617100V-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046963452223), received between Jun 2, 2025 and Feb 12, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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.

• MalfunctionFeb 12, 2026Contamination /Decontamination Problem

  AS REPORTED BY USER FACILITY: A PLASTIC FRAGMENT WAS FOUND INSIDE A NEW SYRINGE FROM HIS SUPPLY SHIPMENT, AND LATER NOTED A SECOND NEW EMPTY SYRINGE ALSO CONTAINED A SMALL PLASTIC PIECE, WHICH HE DID NOT USE AND REPORTED TO HIS NURSE AMBASSADOR. THE PATIENT EXPERIENCED BLISTERING AND BRUISING AT THE CANNULA SITE AFTER REMOVAL; THESE SYMPTOMS RESOLVED WITH RESIDUAL REDNESS. HE ALSO REPORTED NEW INTERMITTENT FLECKS/FLOATERS AND PERIPHERAL VISUAL DISTURBANCES OF UNCERTAIN CAUSE. DURING A SUBSEQUENT VISIT, THE PHYSICIAN EXAMINED THE SKIN AND OBSERVED NO SIGNS OF INFECTION. THE PATIENT STATED THAT THE INTERMITTENT EYE SYMPTOMS CONTINUED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324096 ↗
• MalfunctionJun 2, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: ON (B)(6) 2025, PATIENT REPORTED A PRODUCT QUALITY ISSUE HE EXPERIENCED WITH THE SYRINGE THAT OCCURRED ON (B)(6) 2025. PATIENT REPORTED THAT HE EXPERIENCED HAVING BUBBLES IN THE SYRINGE. PATIENT IS NOTICING THIS AIR BUBBLES TOWARDS THE END OF THE INFUSION, EARLY MORNING WHEN HE WAKES UP. HE STATED THAT THERE WAS LITTLE BUBBLES THAT ACCUMULATED IN THE SYRINGE AND SINCE HE'S SLEEPING ON HIS BACK WHILE THE SYRINGE WAS FACING UP, BUBBLES ARE FORMING, ENOUGH AIR BUBBLES THAT WOULD PUSH THROUGH THE LINE INTO HIS STOMACH AND WHENEVER HE'S REMOVING THE CANNULA, AIR IS COMING OUT OF THE INSERTION SITE. PATIENT MENTIONED THAT ON (B)(6) 2025, HE WAS NOT ABSORBING THE MEDICATION SO THE MEDICATION WAS POOLING AT THE INFUSION SITE THAT CAUSED BURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122655 ↗
• MalfunctionJun 2, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 1 ON (B)(6) 2025, PATIENT REPORTED A PRODUCT QUALITY ISSUE HE EXPERIENCED WITH THE SYRINGE THAT OCCURRED ON (B)(6) 2025. PATIENT REPORTED THAT HE EXPERIENCED HAVING BUBBLES IN THE SYRINGE. PATIENT IS NOTICING THIS AIR BUBBLES TOWARDS THE END OF THE INFUSION, EARLY MORNING WHEN HE WAKES UP. HE STATED THAT THERE WAS LITTLE BUBBLES THAT ACCUMULATED IN THE SYRINGE AND SINCE HE'S SLEEPING ON HIS BACK WHILE THE SYRINGE WAS FACING UP, BUBBLES ARE FORMING, ENOUGH AIR BUBBLES THAT WOULD PUSH THROUGH THE LINE INTO HIS STOMACH AND WHENEVER HE'S REMOVING THE CANNULA, AIR IS COMING OUT OF THE INSERTION SITE. PATIENT MENTIONED THAT ON (B)(6) 2025, HE WAS NOT ABSORBING THE MEDICATION SO THE MEDICATION WAS POOLING AT THE INFUSION SITE THAT CAUSED BURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122353 ↗
• MalfunctionJun 2, 2025Air/Gas in Device; Air/Gas in Device

  AS REPORTED BY THE USER FACILITY: EVENT 2. ON 06-MAY-2025, PATIENT REPORTED A PRODUCT QUALITY ISSUE HE EXPERIENCED WITH THE SYRINGE THAT OCCURRED ON (B)(6) 2025. PATIENT REPORTED THAT HE EXPERIENCED HAVING BUBBLES IN THE SYRINGE. PATIENT IS NOTICING THIS AIR BUBBLES TOWARDS THE END OF THE INFUSION, EARLY MORNING WHEN HE WAKES UP. HE STATED THAT THERE WAS LITTLE BUBBLES THAT ACCUMULATED IN THE SYRINGE AND SINCE HE'S SLEEPING ON HIS BACK WHILE THE SYRINGE WAS FACING UP, BUBBLES ARE FORMING, ENOUGH AIR BUBBLES THAT WOULD PUSH THROUGH THE LINE INTO HIS STOMACH AND WHENEVER HE'S REMOVING THE CANNULA, AIR IS COMING OUT OF THE INSERTION SITE. PATIENT MENTIONED THAT ON (B)(6) 2025, HE WAS NOT ABSORBING THE MEDICATION SO THE MEDICATION WAS POOLING AT THE INFUSION SITE THAT CAUSED BURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122352 ↗