IntellaTip MiFi™ Open-Irrigated M004PM9620K20Recalls & reported problems
Boston Scientific Corporation · Ablation Catheter · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729848691), received between Mar 29, 2018 and Mar 29, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Kinked” (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
Device problems
- Kinked1
- Signal Artifact/Noise1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2018Signal Artifact/Noise; Kinked; Signal Artifact/Noise; Kinked
REPORTABLE BASED ON ANALYSIS COMPLETED MARCH 07, 2018. IT WAS REPORTED AN INTELLATIP MIFI¿ OI ABLATION CATHETER WAS SELECTED FOR USE. THE CATHETER HAD A KINKED TIP AND NOISE WAS OBSERVED ON MULTIPLE MIFI ELECTROGRAMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER AND THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SECTION OF THE RING AROUND MINI ELECTRODE THREE WAS MISSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7380907 ↗
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, ClassifiedBlazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump
Other catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices
- QDOT MICRO D139505Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter27 deaths915 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR96200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 deaths269 reports
- QDOT MICRO D139504Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter7 deaths138 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 recall5 deaths77 reports
- QDOT MICRO D139401Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths114 reports
- NaviStar ThermoCool NI75TCDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter111 reports
- NaviStar RMT ThermoCool NR7TCSIYBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter9 deaths103 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR9620K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter78 reports
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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