IntellaTip MiFi™ Open-Irrigated M004PM9620N40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729848707), received between Jul 25, 2018 and Dec 23, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (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 23, 2020Material Integrity Problem; Material Integrity Problem

  DURING AN ABLATION PROCEDURE A INTELLATIP MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. IT WAS REPORTED THAT IRRIGATION FLUSH PORT DETACHMENT WAS NOTED ON THE CATHETER DURING PREPARATION. THE CATHETER WAS UNABLE TO FLUSH APPROPRIATELY. THE DEVICE WAS EXCHANGED AND THE PROCEDURE RESUMED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11065057 ↗
• MalfunctionFeb 12, 2019Positioning Problem; Positioning Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16JAN2019. IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO MOVE/STEER. DURING PREPARATION FOR A MYOCARDIAL ABLATION PROCEDURE FOR ATRIAL FLUTTER WITH AN INTELLATIP MIFI OI ABLATION CATHETER, THE BEND LEVER WAS DIFFICULT TO USE BECAUSE IT WAS VERY HARD. EVEN THOUGH AN ADJUSTMENT WAS MADE, IT WAS STILL VERY HARD AND IT WAS DIFFICULT TO USE. THE PROCEDURE WAS PERFORMED USING ANOTHER LOT OF SAME DEVICE. NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS OCCURRED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED FLUID UNDER RING 1 PROXIMAL SEAL AND ELECTRODE. THE DEVICE WAS RETURNED FOR ANALYSIS. DRIED, RUST COLORED FLUID WAS UNDER RING 1 PROXIMAL SEAL AND ELECTRODE. DRIED BODY FLUID FOUND ON THE HANDLE, MAIN BODY AND DISTAL END. DRIED SALINE FOUND ON THE DISTAL END AND INSIDE THE IRRIGATION PORTS. TIP MOTION WAS EVALUATED AGAINST A CURVE TEMPLATE. BOTH CURVES REACHED THE SPECIFIED TEMPLATE AREA. THE STEERING KNOB AND TENSION CONTROL KNOB FUNCTIONED PROPERLY ON BOTH LOCK AND UNLOCK POSITIONS, HOWEVER BOTH KNOBS REQUIRED ABNORMAL EFFORT TO ROTATE. X-RAY FOUND NO ANOMALIES. THE STEERING AND TENSION KNOBS WERE REMOVED TO INSPECT THE O-RINGS. EACH O-R

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8333103 ↗
• MalfunctionJul 25, 2018Device Sensing Problem; Device Sensing Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19-JULY-2018. IT WAS REPORTED THAT THE CATHETER HAD HIGH SENSOR TEMPERATURE DISPLAY. A 7.5/110/2.5/4.5 N4 INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER WAS SELECTED FOR AN ABLATION PROCEDURE. DURING PREPARATION, NO VISUAL ISSUE WAS OBSERVED ON THE CATHETER. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE CATHETER HAD HIGH SENSOR TEMPERATURE DISPLAY WHEN INSERTED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS AND NO INJURIES WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BODY FLUID INGRESS WAS FOUND UNDER THE RING 1 DISTAL SEAL AND ALONG THE DISTAL EDGE OF THE RING 1 ELECTRODE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7718294 ↗

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