INTERA AP-07004 (REF AP07004)Recalls & reported problems

Intera Oncology Inc. · Intera 3000 Hepatic Artery Infusion Pump OR Prep Kit, Contents: (1) Huber Needle 22 Gauge, (1) Special Bolus Needle, (1) Empty Syringe Barrel with Lid · Class 3

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850014110154), received between Aug 19, 2025 and Jan 13, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fluid/Blood Leak3

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 13, 2026Fluid/Blood Leak
INTERA ONCOLOGY WAS NOTIFIED BY A PHYSICIAN THAT ON (B)(6) 2025, DURING OR PUMP PREP, THE OR PREP KIT HAD A LEAK BETWEEN THE NEEDLE AND THE TUBING. THE CONNECTION WAS VERY TIGHT BUT THERE WAS STILL LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24056760 ↗
MalfunctionSep 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN THAT DURING PUMP PREPARATION, THE PUMP WAS FILLED WITH 5ML'S, THE SCRUB TECH NOTICED A LEAK BETWEEN THE NEEDLE AND TUBING. AN INTERA ONCOLOGY REPRESENTATIVE INSTRUCTED THE PHYSICIAN TO CLAMP THE CENTER OF THE TUBING, BUT THE LEAK CONTINUED, LIKELY FROM THE 5ML'S IN THE PUMP PUSHING BACK. OUR REPRESENTATIVE INSTRUCTED THE PHYSICIAN TO PULL THE NEEDLE OUT OF THE PUMP AND TIGHTEN THE CONNECTION AS HARD AS SHE COULD WITH HER HANDS. SHE DID THEN INSERT THE NEEDLE BACK IN THE PUMP, THE LEAK CONTINUED. OUR REPRESENTATIVE THEN INSTRUCTED THE PHYSICIAN TO PULL THE NEEDLE FROM THE PUMP AND USE SOME HEMOSTATS TO FULLY SECURE THE CONNECTION. AFTER THIS THERE WAS NO MORE LEAKING AT THE CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23043343 ↗
MalfunctionAug 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
INTERA ONCOLOGY RECEIVED A REPORT THAT DURING PUMP PREPARATION THE TUBING FROM THE OR PREP KIT WAS LEAKING NEAR WHERE IT CONNECTED WITH THE REFILL NEEDLE. ONCE THE CLINIC NOTICED THE LEAK, THEY REPLACED THE TUBING BY OPENING A NEW OR PREP KIT. THE PUMP PREPPED FINE AFTERWARDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841456 ↗

Device details

UDI-DI	`00850014110154`
Brand	INTERA
Model	AP-07004
Catalog no.	AP07004
Company	Intera Oncology Inc.
Product code	LKK · Pump, Infusion, Implanted, Programmable
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jul 9, 2026

Device type (GMDN): Hypodermic needle, single-use

A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

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All Pump, Infusion, Implanted, Programmable devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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