INTERA AP-04013-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850014110048), received between Jun 18, 2025 and Jan 30, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Difficult to Flush

  INTERA ONCOLOGY WAS NOTIFIED THAT DURING PUMP PREPARATION FOR AN IMPLANT ON (B)(6) 2026, THE SCRUB TECH WASN'T ABLE TO FLUSH THE PUMP BOLUS PATHWAY WITH LOW DOSE HEPARINIZED SALINE. THEY OPENED THE BACKUP SPECIAL BOLUS NEEDLE AND WAS ABLE TO FLUSH THE PUMP BOLUS PATHWAY. THE PUMP WAS SUCCESSFULLY IMPLANTED AND THE CLINIC SET THE MALFUNCTIONED NEEDLE ASIDE TO BE EXAMINED BY INTERA ONCOLOGY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24227113 ↗
• MalfunctionJun 18, 2025Defective Component; Defective Component

  INTERA ONCOLOGY RECEIVED A REPORT FROM OUR REPRESENTATIVE THAT HE AND THE PHYSICIAN NOTICED DURING AN IMPLANTATION ON (B)(6) 2025, THAT THE SPECIAL BOLUS NEEDLE WAS EXPERIENCING BACKFLOW OF BLOOD, EVEN THOUGH THE NEEDLE WAS CLAMPED WHEN NOT IN USE. OUR REPRESENTATIVE INSTRUCTED THE SCRUB TECH TO UNCLAMP THE NEEDLE AND INJECT 5 ML OF LOW-DOSE HEPARINIZED SALINE TO CLEAR THE BLOOD, THEN RECLAMP IT IMMEDIATELY AFTERWARD. HOWEVER, ONE TO TWO MINUTES LATER, BLOOD WAS AGAIN FLOWING BACK INTO THE NEEDLE AND SYRINGE, DESPITE THE CLAMP BEING IN PLACE. THE NEEDLE WAS REMOVED, AND THE SPARE SPECIAL BOLUS NEEDLE WAS OPENED. WITH THE SPARE NEEDLE, THERE WERE NO ISSUES OF BACKFLOW INTO THE NEEDLE OR SYRINGE WHEN CLAMPED. DURING COMMUNICATION WITH THE CLINIC, THE SURGEON CONFIRMED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE REACTIONS. IN ADDITION, THE CLINIC PROVIDED INTERA ONCOLOGY WITH THREE PICTURES THAT SHOW THE SPECIAL BOLUS NEEDLE EXPERIENCING BACKFLOW OF BLOOD, EVEN THOUGH THE NEEDLE WAS CLAMPED WHEN NOT IN USE. DUE TO SAFETY CONCERNS FOR CONTAMINATED NEEDLE, INTERA ONCOLOGY ASKED THE CLINIC TO DISPOSE THE SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286574 ↗