INTELLAGEN™ Irrigation Pump Kit 20402Recalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260166374087), received between Aug 20, 2025 and Aug 20, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Power Up” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Failure to Power Up1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionAug 20, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE PUMP DID NOT POWER UP, AND THE PROCEDURE WAS CANCELLED. AN INTELLAGEN IRRIGATION PUMP KIT WAS USED FOR A REDO PULMONARY VEIN ISOLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (AF). DURING PREPARATION, ALL CONNECTIONS WERE DONE AND THE SYSTEM WAS POWERED UP; HOWEVER, THE IRRIGATION PUMP DID NOT POWER UP. THE PREPARATION WAS CONTINUED AND TRIED TO DISCONNECT AND RECONNECT THE PUMP AND THEN POWER IT UP, BUT STILL DID NOT POWER UP. THERE WERE NO AUDIBLE NOISES, AND NO LED LIGHTS TURNED ON, AS IF THE POWER SUPPLY WAS NOT CONNECTED. SUBSEQUENTLY, SEVERAL POWER OUTLETS AND CABLES WERE TESTED, BUT NONE OF THEM WORKED. THE DEVICE WAS LEFT PLUGGED IN FOR SEVERAL MINUTES TO RULE OUT IF THE INTERNAL BATTER NEEDS PRE-CHARGING. THE SAFETY CATCH ON TOP OF THE POWER PLUG WAS INSPECTED AND APPEARED TO BE IN GOOD CONDITION. THE ACCOUNT CONTACTED THE FIELD SERVICE ENGINEER (FSE) THAT INSTALLED THE PRODUCT AND WAS ADVISED TO REACH OUT TO CE TECHNICAL SUPPORT, BUT THEY WERE UNABLE TO ASSIST. AFTER WAITING FOR 30 MINUTES, THE PHYSICIAN DECIDED TO CANCEL THE CASE. THE PATIENT WAS SEDATED UNDER GENERAL ANESTHESIA, AND NO COMPLICATIONS WERE REPORTED. THE DEVICE WILL BE DEINSTALLED A
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22851047 ↗

Device details

UDI-DI	`04260166374087`
Brand	INTELLAGEN™ Irrigation Pump Kit
Model	20402
Catalog no.	M004GEN100204020
Company	Stockert GmbH
Product code	OAD · Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Class	Class 3
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 19, 2026

Device type (GMDN): Bedside infusion pump, single-channel

An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.

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All Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter 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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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