INTELLAGEN™ Tubing Set 20626Recalls & reported problems
Stockert GmbH · Only commercialized as part of the 10 PK · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260166374346), received between Nov 19, 2025 and Jan 15, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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
Most reported problems
Device problems
- Insufficient Flow or Under Infusion1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Nonstandard Device
IT WAS REPORTED THAT THE THREE-WAY STOPCOCK WAS LOOSE. A INTELLAGEN TUBING SET WAS SELECTED FOR AN ATRIAL FIBRILLATION ABLATION PROCEDURE. DURING THE PROCEDURE, THE THREE-WAY STOPCOCK WAS LOOSE AND WOULD NOT PROPERLY CLOSED. THE TUBING WAS REPLACED WITH ANOTHER OF THE SAME DEVICE, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS FOR THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISPOSED OF BY THE FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24082276 ↗MalfunctionNov 19, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
IT WAS REPORTED THAT NO FLUID CAME OUT FROM THE CATHETER WHEN FLUSHING WAS ATTEMPTED. DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE, AN INTELLAGEN TUBING SET AND AN INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER WERE SELECTED FOR USE IN THE LEFT ATRIUM. DURING PREPARATION, FLUSHING WAS ATTEMPTED OUTSIDE THE PATIENT'S BODY, BUT NO FLUID CAME OUT FROM THE CATHETER. BOTH COMPONENTS WERE REPLACED TO RESOLVE THE PROBLEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. NOTE: THIS REPORTED PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 2124215-2025-84375 FOR THE ASSOCIATED DEVICE INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594901 ↗
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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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