INTELLANAV STABLEPOINT™ M004RFSDS96200Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729992233), received between Jan 28, 2025 and Mar 20, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (3 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTELLANAV STABLEPOINT CATHETER WAS SELECTED FOR A PREMATURE VENTRICULAR COMPLEX (PVC) ABLATION PROCEDURE. THE DAY AFTER THE PROCEDURE WAS PERFORMED, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED AND THE COMPLICATION WAS RESOLVED WITHOUT ANY FURTHER COMPLICATIONS. THE PATIENT WAS THEN SUCCESSFULLY DISCHARGED WITHOUT ANY ISSUES. THE DEVICE IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

  Patient problems: Pericardial Effusion

  MAUDE report 24649500 ↗
• MalfunctionJan 29, 2026Restricted Flow rate; Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE SIDE PORT WAS BENT, CAUSING THE FLUID NOT PROPERLY FLOWING THROUGH THE CATHETER. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, AN INTELLANAV STABLEPOINT CATHETER WAS SELECTED FOR USE. WHILE CONNECTING THE FLUSH TO THE CATHETER, A BEND IN THE FLUSH PORT WAS OBSERVED, CAUSING THE FLUID NOT PROPERLY FLOWING THROUGH THE CATHETER. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WAS RETAINED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211309 ↗
• MalfunctionNov 5, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO IRRIGATE. DURING PREPARATION FOR AV NODE ABLATION TO TREAT RVR ATRIAL FIBRILLATION, AN INTELLANAV STABLEPOINT CATHETER WAS SELECTED FOR USE. IT WAS OBSERVED THAT ONE OF THE FLUSH PORTS WAS OCCLUDED AND DRIPPING INCONSISTENTLY. RUBBING THE OUTSIDE OF THE PORT DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD WITH A DIFFERENT DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WILL NOT BE RETURNED, AS IT WAS RETAINED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477697 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT INTO INTERMITTENT HEART BLOCK. THE PATIENT WAS UNDERGOING TREATMENT FOR SUPRAVENTRICULAR TACHYCARDIA. AN INTELLANAV STABLEPOINT CATHETER WAS SELECTED FOR ABLATION PROCEDURE. DURING PARAHISIAN PACING, THE PATIENT WENT INTO INTERMITTENT HEART BLOCK. NO ABLATION WAS PERFORMED, AND NO MEDICAL OR SURGICAL INTERVENTION WAS DONE. THE PROCEDURE WAS INCOMPLETE. NO FURTHER COMPLICATIONS WERE REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS IT WAS DISPOSED OF.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23359248 ↗
• MalfunctionJul 15, 2025Difficult to Advance; Improper Flow or Infusion; Material Deformation; Difficult to Advance; Improper Flow or Infusion; Material Deformation

  IT WAS REPORTED THAT THERE WAS DIFFICULTY IN ADVANCING THE CATHETER AND OCCLUSION ON THE METRIQ PUMP WAS OBSERVED. FURTHERMORE, THE CATHETER WAS DIFFICULT TO IRRIGATE, AND THE DISTAL END OF THE CATHETER WAS BENT. A STABLEPOINT WAS SELECTED FOR USE TO TREAT ATRIAL FIBRILLATION (AFIB) AND FLUTTER. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN ADVANCING THE CATHETER AND OCCLUSION ON THE METRIQ PUMP WAS OBSERVED. FURTHERMORE, THE CATHETER WAS DIFFICULT TO IRRIGATE, AND THE DISTAL END OF THE CATHETER WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511245 ↗
• MalfunctionJul 11, 2025Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  IT WAS REPORTED THAT A LEAK WAS OBSERVED AT THE CONNECTION BETWEEN THE FLUSH PORT AND THE INTELLEGEN TUBING, AND THE FLUSH PORT AT THE END OF THE CATHETER WAS DAMAGED. AN INTELLANAV STABLEPOINT CATHETER WAS USED TO TREAT ATRIAL FIBRILLATION AND FLUTTER DURING AN ABLATION PROCEDURE. DURING THE PROCEDURE, WHILE MAPPING IN THE RIGHT ATRIUM (RA), A LEAK WAS OBSERVED AT THE CONNECTION BETWEEN THE FLUSH PORT AND THE INTELLEGEN TUBING. THE CATHETER WAS CONNECTED TO THE TUBING AND WAS FLUSHING PROPERLY BEFORE THE PROCEDURE. UPON RESEATING THE CONNECTION, THE PHYSICIAN OBSERVED THAT THE FLUSH PORT AT THE END OF THE CATHETER WAS DAMAGED. NO ABLATIONS WERE PERFORMED PRIOR TO OBSERVING THE ISSUE. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479418 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTELLANAV STABLEPOINT CATHETER WAS SELECTED FOR USE. POST PROCEDURE DURING AN EMERGENT FOLLOW-UP, THE PATIENT EXPERIENCED A SECOND-DEGREE ATRIOVENTRICULAR (AV) BLOCK. THE PATIENT WILL UNDERGO A PACEMAKER IMPLANTATION AT A LATER DATE TO TREAT THE COMPLICATION. THE ISSUE IS ONGOING. CATHETER IS NOT EXPECTED TO BE RETURNED AS IT WAS DISPOSED.

  Patient problems: Heart Block

  MAUDE report 22172524 ↗
• MalfunctionMay 28, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AFTER ONE SUCCESSFUL LESION, A "P02 - OCCLUSION DETECTED" ERROR APPEARED ON THE METRIQ PUMP WHEN ATTEMPTING TO RESUME ABLATION. THE PHYSICIAN DECIDED TO CANCEL THE PROCEDURE DUE TO ITS DURATION. DURING AN ATYPICAL FLUTTER ABLATION PROCEDURE TO TREAT ATRIAL FLUTTER, AN INTELLANAV STABLEPOINT CATHETER WAS USED. AFTER ONE SUCCESSFUL LESION, A "P02 - OCCLUSION DETECTED" ERROR APPEARED ON THE METRIQ PUMP WHEN ATTEMPTING TO RESUME ABLATION. SUBSEQUENTLY, THE CATHETER WAS REMOVED FROM THE BODY AND PURGED, WITH NO OCCLUSION NOTED, AND STANDBY FLOW RESUMED. THE CATHETER WAS THEN REINSERTED, BUT THE SAME ERROR OCCURRED WHEN ABLATION WAS ATTEMPTED AGAIN. THE PHYSICIAN DECIDED TO CANCEL THE PROCEDURE DUE TO ITS DURATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22102108 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, AN INTELLANAV STABLEPOINT CATHETER WAS SELECTED FOR USE. AT THE END OF THE CASE, THE PATIENT WENT INTO TYPICAL ATRIAL FLUTTER. THE PHYSICIAN USED A STANDARD CURVE STABLEPOINT CATHETER TO ABLATE THE CTI. DURING ABLATION, THE PHYSICIAN WAS NOTIFIED BY THE BSC CLINICAL SPECIALIST MANY TIMES THAT HIGH FORCE WAS BEING REPORTED ON THE CATHETER. STANDARD PROTOCOL WAS FOLLOWED TO WARM UP THE STABLEPOINT CATHETER AND WAS ZERO'D WHILE FLOATING IN THE ATRIUM; NO ERRORS WERE APPEARING OTHERWISE ON THE CATHETER SO THE HIGH FORCE READINGS WERE ASSUMED TO BE ACCURATE. PHYSICIAN IGNORED WARNINGS FROM THE CLINICAL AND FROM THE OPAL SOFTWARE FLASHING RED ON THE SCREEN AND CONTINUED TO ABLATE AT FORCES OF 80+ GRAMS THROUGHOUT THE CASE. AN ULTRASOUND CLINICAL SPECIALIST NOTIFIED THE PHYSICIAN THAT SHE SAW A PERICARDIAL EFFUSION FORMING AROUND THE RIGHT ATRIUM. PHYSICIAN ATTEMPTED TO GET BETTER VIEWS ON THE ULTRASOUND MACHINE AND DIAGNOSE THIS ISSUE. HE DID NOT SEE AN EFFUSION AND CONTINUED TO ABLATE TO FINISH WITH BI-DIRECTIONAL BLOCK ON THE CTI LINE. OVERNIGHT, THE PATIENT WAS DIAGNOSED TO HAVE A PERICARDIAL EFFUSION THAT REQUIRED A PERICARDIAL WINDO

  Patient problems: Pericardial Effusion

  MAUDE report 21952982 ↗
• MalfunctionFeb 25, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE DEVICE HAD AN IMPEDANCE ISSUE AND SUBSEQUENTLY THE PROCEDURE WAS CANCELLED. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION/FLUTTER, AN INTELLANAV STABLEPOINT CATHETER WAS SELECTED FOR USE. THE CATHETER WAS INSERTED INTO THE RIGHT ATRIUM, CONNECTIONS WERE ALL GOOD. WHEN RADIOFREQUENCY WAS STARTED, THERE WAS NO IMPEDANCE DROP DESPITE HAVING 20 GRAMS OR MORE OF CONTACT FORCE AND A GROUNDING PAD ON THE PATIENT'S THIGH. (STARTING IMPEDANCE WAS AROUND 150.) TROUBLE SHOOTING WAS PERFORMED; THE CONNECTIONS WERE DISCONNECTED AND RE-CONNECTED AND A SIGNAL DISPLAYED ON THE SYSTEM. THE FLOW RATE OF THE CATHETER WAS CHANGED FROM 30ML TO 17ML, BUT THE ISSUE PERSISTED. DUE TO NO IMPEDANCE DROP, THE PHYSICIAN CHOSE TO DISCONTINUE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS IS BEING REPORTED FOR PROCEDURE CANCELLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459879 ↗
• MalfunctionFeb 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT ATRIAL FIBRILLATION/FLUTTER (AFIB/FLUTTER), AN INTELLANAV STABLEPOINT CATHETER WAS SELECTED FOR USE. IT WAS OBSERVED THAT STABLEPOINT FLUSH PORT WAS LEAKING, SPRAYING FLUID OUT OF THE PROXIMAL FLUSHPORT/STOPCOCK CONNECTOR. NO ERROR MESSAGE WAS DISPLAYED AND NO DAMAGE TO THE LUER WAS NOTICED. FLOW RATE WAS SET AS FAST FLUSH FOR PREPARATION. CATHETER WAS THEN REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309426 ↗
• MalfunctionJan 28, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT A SUPRA VENTRICULAR TACHYCARDIA, AN INTELLANAV OPEN IRRIGATED CATHETER WAS SELECTED FOR USE. THE CATHETER WAS NOT FLUSHING CORRECTLY WHEN DOING AN INPATIENT ABLATION. THERE WAS NO INTERRUPTION OF IRRIGATION FROM THE PUMP. THE FLOW RATE WAS SET AT FAST FLUSH AT THE BEGINNING. TRIED RECONNECTING THE FLUSH AND FLUSHING MULTIPLE TIMES BUT THE ISSUE PERSISTED. FINALLY, CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256502 ↗

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