IntellaNav™ Open-Irrigated M004R9620N40Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729937456), received between Dec 22, 2016 and Sep 19, 2019 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2019Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE CATHETER TEMPERATURE WAS STUCK AT 20 DEGREES CELSIUS. DURING AN ABLATION PROCEDURE, WHEN THE INTELLANAV OPEN-IRRIGATED CATHETER WAS INSERTED INTO THE HEART, THE TEMPERATURE WAS DISPLAYED AT 20 DEGREES CELSIUS, SO THE CABLE WAS REPLACED. THE ISSUE DID NOT IMPROVE SO THE CATHETER WAS REPLACED, WHICH RESOLVED THE ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9090431 ↗
• MalfunctionJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28JUN2019. THE DEVICE WAS RETURNED WITHOUT A COMPLAINT. DEVICE ANALYSIS FOUND THE ADHESIVE AND IRRIGATION TUBING TORE OPEN AT THE PROXIMAL (NARROWEST) SIDE OF THE ADHESIVE JOINT SECURING THE TUBING TO THE LUER FITTING. THE TEAR CAUSED THE LUER FITTING TO SEPARATE FROM THE TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802846 ↗
• InjuryAug 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2017-08395 AND 2134265-2017-08396. IT WAS REPORTED A PERICARDIAL EFFUSION OCCURRED. AN INTELLAMAP ORION¿ MAPPING CATHETER, POLARIS X¿ DIAGNOSTIC CATHETER, AND AN INTELLANAV OI ABLATION CATHETER WERE USED DURING A PULMONARY VEIN ABLATION PROCEDURE BEING CONDUCTED TO TREAT ATRIAL FIBRILLATION. DURING THE PROCEDURE THE PHYSICIAN NOTICED A PERICARDIAL EFFUSION. THE PHYSICIAN FELT THE EFFUSION OCCURRED DURING MAPPING, BUT WAS UNCERTAIN WHICH CATHETER CAUSED OR CONTRIBUTED TO THE EVENT. IT WAS NOTED THERE HAD BEEN NO DEVICE PERFORMANCE ISSUES. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT UNDERWENT SURGERY TO REPAIR THE HOLE. THE PATIENT WAS DOING ¿VERY WELL¿ AND WAS IN STABLE CONDITION.

  Patient problems: Pericardial Effusion

  MAUDE report 6824439 ↗
• MalfunctionAug 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 14 AUGUST 2017. IT WAS REPORTED THAT THERE WAS NOISE ELECTROGRAM (EGM). DURING A LEFT ATRIAL FLUTTER CASE THE PHYSICIAN WAS UNABLE TO PERFORM A PULMONARY VEIN ISOLATION (PVI) DUE TO NOISE IN THE EGM. THE BARD GROUND CABLE WAS DISCONNECTED AND THE PATIENT GROUND CABLES WERE ROUTED OVER THE PATIENT AS RECOMMENDED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED FOREIGN MATERIAL ON THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6813215 ↗
• MalfunctionAug 3, 2017Failure to Sense; Failure to Sense

  REPORTABLE BASED ON ANALYSIS COMPLETED JULY 13, 2017. IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, AFTER OVER FOUR HOURS OF USE, THE ASYMMETRIC CURVE INTELLANAV OI ABLATION CATHETER STOPPED MAGNETICALLY TRACKING. A STANDARD CURVE INTELLANAV OI ABLATION CATHETER WAS USED TO REGAIN MAGNETIC TRACKING AND COMPLETE THE PROCEDURE. THE PATIENT WAS NOT HARMED IN ANY WAY DURING THE PROCEDURE; THE PATIENT WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE BUTT BOND HAD BEEN SEPARATED AND BODY FLUID WAS IDENTIFIED INSIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6763575 ↗
• MalfunctionDec 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A STEAMPOP OCCURRED. THE TARGET LOCATION WAS THE MITRAL ANNULUS IN THE LEFT ATRIUM. DURING THE USE OF A INTELLANAV OI CATHETER, A STEAM POP OCCURRED. THE PROCEDURE WAS ABLE TO BE COMPLETED "NORMALLY". NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE/STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6198145 ↗

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