Devices › Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Device brand name · Catheter percutaneous cardiac ablation for treatment of atrial fibrillation
TactiFlex Ablation Catheter, Sensor Enabled: medical device reports filed with FDA
514 reports name it, 2020–2026. Manufacturer given most often on reports: St Jude Medical. Product code OAE.
- 514
- device reports naming the brand
- 0% of all MAUDE reports · about 89 a year
- 164
- reports, 12 months to August 2026
- 154 in the 12 months before
- 47.3%
- classified as malfunction
- 49% across the product code
- 3.7%
- classified as death, as reported
- 19 reports · not verified by FDA
514 medical device reports received by FDA name the brand "TactiFlex Ablation Catheter, Sensor Enabled" (catheter percutaneous cardiac ablation for treatment of atrial fibrillation); the manufacturer given most often on reports is St Jude Medical; received from October 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
164 reports arrived in the 12 months to August 2026, close to the 154 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (49%), malfunction (47.3%) and death (3.7%); across all catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation reports (product code OAE) death is recorded in 3% and malfunction in 49%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are communication or transmission problem (14.6%), optical problem (11.5%) and overheating of device (7.8%). The patient problems coded most often are cardiac perforation, heart block and stenosis. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 11,466 reports carrying product code OAE. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Communication or transmission problemthe device could not communicate or transmit | 75 | 14.6% | 2.9% |
| Optical problem | 59 | 11.5% | 4.3% |
| Overheating of device | 40 | 7.8% | 0.5% |
| Signal artifact/noise | 25 | 4.9% | 1% |
| Material separation | 20 | 3.9% | 0.3% |
| Patient device interaction problem | 20 | 3.9% | 8.3% |
| Display or visual feedback problem | 14 | 2.7% | 0.7% |
| Electrical shorting | 11 | 2.1% | 1.1% |
| Fracturea broken bone | 11 | 2.1% | 2.1% |
| Improper or incorrect procedure or method | 10 | 1.9% | 0.3% |
| Material deformation | 8 | 1.6% | 1.6% |
| Impedance problem | 7 | 1.4% | 0.4% |
| Failure to deliver energy | 6 | 1.2% | 0.1% |
| Air/gas in device | 3 | 0.6% | 0% |
| Device contamination with body fluid | 3 | 0.6% | 5.8% |
| Off-label use | 3 | 0.6% | 0.3% |
| Temperature problem | 3 | 0.6% | 1.3% |
| Connection problema connection problem | 2 | 0.4% | 0.2% |
| Contamination /decontamination problem | 2 | 0.4% | 1.2% |
| Entrapment of device | 2 | 0.4% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Cardiac perforation | 173 | 33.7% |
| Heart block | 17 | 3.3% |
| Stenosis | 14 | 2.7% |
| Stroke/cva | 13 | 2.5% |
| Thrombosis/thrombus | 10 | 1.9% |
| Arrhythmia | 9 | 1.8% |
| Foreign body in patientpart of a device left in the patient | 7 | 1.4% |
| Vascular dissection | 7 | 1.4% |
| Perforation of esophagus | 6 | 1.2% |
| Air embolism | 5 | 1% |
| Pericardial effusionfluid around the heart | 5 | 1% |
| Cardiac arrestthe heart stopped | 4 | 0.8% |
| Cardiac tamponade | 4 | 0.8% |
| Great vessel perforation | 4 | 0.8% |
| Low blood pressure/ hypotension | 4 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | TactiFlex Ablation Catheter, Sensor Enabled | Product code OAE | All MAUDE reports |
|---|---|---|---|
| Reports | 514 | 11,466 | 26,136,888 |
| Share of that pool | — | 4.5% | 0% |
| Classified as death, per 1,000 reports | 37 | 30 | 9 |
| Classified as injury | 49% | 47.9% | 36.2% |
| Classified as malfunction | 47.3% | 49% | 62.3% |
| Filed by the manufacturer | 100% | 97.6% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code OAE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Arctic Front Advance Cardiac Cryoablation Catheter | 2,364 | 46 | 2.6% |
| Arctic Front Advance Pro Cardiac Cryoablation Catheter | 1,727 | 152 | 2.5% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve D-F | 1,088 | 38 | 2.4% |
| QDOT Micro | 1,169 | 390 | 3% |
| Tacticath Quartz Contact Force Ablation Catheter 75mm | 633 | 0 | 3.3% |
| Qdot Micro Catheter | 538 | 37 | 3.5% |
| IntellaNav StablePoint Open-Irrigated | 376 | 33 | 1.1% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled | 305 | 34 | 6.9% |
| Polarxfit | 235 | 17 | 1.7% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled BiD Curve F-J | 219 | 6 | 2.7% |
| Tacticath Quartz Contact Force Ablation Catheter 65mm | 208 | 0 | 3.8% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled UniD Curve D | 188 | 11 | 1.6% |
| Heartlight | 206 | 0 | 1% |
| Tactisys Quartz Ablation System | 155 | 16 | 0% |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled UniD Curve F | 151 | 4 | 4% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about TactiFlex Ablation Catheter, Sensor Enabled reports
How many FDA reports name TactiFlex Ablation Catheter, Sensor Enabled?
514 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 164 in the latest 12 months.
What kinds of events are reported?
injury (49%), malfunction (47.3%) and death (3.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
communication or transmission problem (14.6%), optical problem (11.5%), overheating of device (7.8%), signal artifact/noise (4.9%) and material separation (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that TactiFlex Ablation Catheter, Sensor Enabled was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.