INTELLANAV STABLEPOINT™ M004RFSDS9620K20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729992240), received between Dec 12, 2024 and Dec 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

1 other recall cover devices cleared under the same FDA submission (P150005); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 18, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CATHETER COULD NOT BE SUFFICIENTLY IRRIGATED. DURING PREPARATION FOR A PROCEDURE TO TREAT ATRIAL FIBRILLATION AN INTELLANAV STABLEPOINT CATHETER WAS SELECTED FOR USE. PRIOR TO INSERTION SOME FLUSH PORTS WERE OCCLUDED WHEN ATTEMPTING THE FAST FLUSH; TWO OR THREE WERE ACTUALLY SPRAYING AND THE CATHETER COULD NOT BE PROPERLY FLUSHED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO DISPOSAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840300 ↗
• MalfunctionOct 28, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE ERROR MESSAGE "THE FOLLOWING ELECTRODES HAVE POOR SIGNAL QUALITY- ELECTRODE LABEL" WAS DISPLAYED. THIS IS BEING REPORTED FOR CANCELLATION OF THE PROCEDURE POST SEDATION. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (AFIB), AN INTELLANAV STABLEPOINT CATHETER WAS USED. WHEN CONNECTING THE DEVICE, SIGNIFICANT SIGNAL WAS OBSERVED ON BARD ON THE DISTAL ELECTRODE, AND THE OPAL SYSTEM WAS CONFIRMED TO BE WORKING PROPERLY. HOWEVER, THE ERROR MESSAGE "THE FOLLOWING ELECTRODES HAVE POOR SIGNAL QUALITY- ELECTRODE LABEL" APPEARED. TROUBLESHOOTING STEPS INCLUDED RECONNECTING THE SIGNAL STATION AND CHECKING THE REFERENCE PATCH AND BOTH GROUND PADS. DESPITE TROUBLESHOOTING, THE PROCEDURE WAS CANCELLED DUE TO TECHNICAL PROBLEMS AND POOR ANATOMICAL CONTACT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE HAS BEEN RECEIVED AND IS PENDING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410395 ↗
• MalfunctionDec 12, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO FLUSH. DURING PREPARATION FOR AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, AN INTELLANAV STABLEPOINT CATHETER WAS SELECTED FOR USE. UPON OPENING AND CONNECTION OF THE CATHETER TO THE TUBING, THE CATHETER WOULD NOT FLUSH. THE PUMP WAS BYPASSED AND MANUAL FLUSHING VIA A SYRINGE WAS ATTEMPTED BUT WAS UNSUCCESSFUL. NO ERROR MESSAGES WERE DISPLAYED. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918744 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150005. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2019 · Nov 28, 2018 · Open, Classified
  Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump