INTERA AP-04009Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850014110017), received between May 14, 2025 and May 14, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  INTERA ONCOLOGY RECEIVED A REPORT OF A REFILL KIT LEAK. ON (B)(6) 2025, A REPRESENTATIVE FROM INTERA ONCOLOGY WAS SUPPORTING A PUMP IMPLANTATION WITH THE CLINIC. THE SCRUB ATTACHED THE REFILL NEEDLE TO THE OR PREP KIT SYRINGE AND TUBING SET; THE SCRUB ENSURED THE TUBING AND NEEDLE CONNECTION WAS SECURE. THE SCRUB INSERTED THE NEEDLE PERPENDICULAR TO THE SEPTUM AND DEPRESSED THE NEEDLE DOWN UNTIL SHE FELT THE NEEDLE STOP. THE BACTERIOSTATIC WATER BEGAN FILLING THE SYRINGE BUT WAS SIMULTANEOUSLY LEAKING WHERE THE NEEDLE AND TUBING WERE CONNECTED. THE REPRESENTATIVE FROM INTERA ONCOLOGY ASKED THE SCRUB TO CLAMP THE TUBING, REMOVE THE NEEDLE AND CONFIRM THAT THE NEEDLE WAS TIGHT, SHE CONFIRMED IT WAS TIGHT. THE SCRUB ATTEMPTED AGAIN, AND THE WATER CONTINUED TO LEAK AT THE NEEDLE AND TUBING CONNECTION. THE SCRUB WAS INSTRUCTED BY INTERA'S REPRESENTATIVE TO REMOVE THE NEEDLE AND ATTACH THE BACKUP NEEDLE. THE SCRUB CONNECTED THE BACKUP NEEDLE AND THERE WAS NO FURTHER LEAKAGE. THE ALLEGED NEEDLE WAS SEPARATED AND SHIPPED TO INTERA ONCOLOGY HEADQUARTERS. THE NEEDLE ARRIVED AT INTERA ONCOLOGY HEADQUARTERS ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022867 ↗