ONCONTROL IPN919016Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156108472), received between Feb 22, 2023 and Feb 22, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 22, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT: DURING BONE MARROW PROCEDURE, THE ACCESS NEEDLE BROKE OFF AT THE HUB. AFTER THE DEVICE BROKE OFF AT THE HUB A HEMOSTAT WAS USED TO TRY TO REMOVE THE NEEDLE THAT WAS IN ILIAC. NEEDLE BROKE AGAIN MID SHAFT UNDER THE SKIN. PATIENT WAS SENT TO SURGERY TO REMOVE THE REMAINDER OF THE NEEDLE. ADDITIONAL INFORMATION ON 13FEB2023: DURING A BONE MARROW PROCEDURE ON THE (B)(6) 2023 THE CANNULA BROKE OFF AT THE LEVEL OF THE DEPTH GAUGE. AT THAT POINT THE CANNULA WAS STICKING OUT OF PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE CANNULA THAT WAS STUCK IN BONE WITH A HEMOSTAT. THE CANNULA BROKE AGAIN LEAVING THE REST IN THE BODY. THE PATIENT WAS THEN SENT TO SURGERY WHERE THEY SUCCESSFULLY REMOVED THE CANNULA IN ITS ENTIRETY. THE PATIENT WAS REPORTED AS FINE POST THE INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16416291 ↗