Devices › Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation
Device brand name · Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with
Affera: medical device reports filed with FDA
1,159 reports name it, 2024–2026. Manufacturer given most often on reports: Medtronic. Product code QZI.
- 1,159
- device reports naming the brand
- 0% of all MAUDE reports · about 699 a year
- 992
- reports, 12 months to August 2026
- 167 in the 12 months before
- 32.4%
- classified as malfunction
- 52.5% across the product code
- 2.1%
- classified as death, as reported
- 24 reports · not verified by FDA
1,159 medical device reports received by FDA name the brand "Affera" (percutaneous cardiac ablation catheter for treatment of atrial fibrillation with); the manufacturer given most often on reports is Medtronic; received from November 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
992 reports arrived in the 12 months to August 2026, up 494% from 167 in 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 (65.6%), malfunction (32.4%) and death (2.1%); across all percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation reports (product code QZI) death is recorded in 2.3% and malfunction in 52.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device contamination with chemical or other material (9.9%), coagulation in device or device ingredient (2.4%) and electromagnetic compatibility problem (1.6%). The patient problems coded most often are stroke/cva, heart block and pericardial effusion. 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 9,434 reports carrying product code QZI. 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 |
|---|---|---|---|
| Device contamination with chemical or other material | 115 | 9.9% | 5.2% |
| Coagulation in device or device ingredient | 28 | 2.4% | 0.9% |
| Electromagnetic compatibility problem | 18 | 1.6% | 0.2% |
| Radiofrequency interference (rfi) | 13 | 1.1% | 0.1% |
| Contamination | 12 | 1% | 3.3% |
| Device-device incompatibility | 10 | 0.9% | 0.8% |
| Off-label use | 7 | 0.6% | 6.8% |
| Electromagnetic interference | 6 | 0.5% | 0.1% |
| Entrapment of device | 6 | 0.5% | 11% |
| Communication or transmission problemthe device could not communicate or transmit | 4 | 0.3% | 0.7% |
| Contamination /decontamination problem | 4 | 0.3% | 0.1% |
| Electrical /electronic property probleman electrical or electronic problem | 4 | 0.3% | 0.2% |
| Computer operating system problem | 3 | 0.3% | 0% |
| Device sensing problem | 3 | 0.3% | 0.1% |
| Excessive heating | 3 | 0.3% | 0% |
| Circuit failure | 2 | 0.2% | 0% |
| Delivered as unsterile product | 2 | 0.2% | 0.3% |
| Device contamination with body fluid | 2 | 0.2% | 0.1% |
| Display or visual feedback problem | 2 | 0.2% | 0.1% |
| Failure to transmit record | 2 | 0.2% | 0.1% |
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 |
|---|---|---|
| Stroke/cva | 113 | 9.7% |
| Heart block | 84 | 7.2% |
| Pericardial effusionfluid around the heart | 76 | 6.6% |
| Tachycardiafast heart rate | 74 | 6.4% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 74 | 6.4% |
| Low blood pressure/ hypotension | 56 | 4.8% |
| Cardiac tamponade | 40 | 3.5% |
| Non specific ekg/ECG changes | 39 | 3.4% |
| Atrial fibrillationan irregular heart rhythm | 31 | 2.7% |
| Arrhythmia | 29 | 2.5% |
| Atrial flutter | 28 | 2.4% |
| Bradycardiaslow heart rate | 27 | 2.3% |
| Hemorrhage/blood loss/bleeding | 25 | 2.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 24 | 2.1% |
| Cardiac arrestthe heart stopped | 23 | 2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Affera | Product code QZI | All MAUDE reports |
|---|---|---|---|
| Reports | 1,159 | 9,434 | 26,136,888 |
| Share of that pool | — | 12.3% | 0% |
| Classified as death, per 1,000 reports | 21 | 23 | 9 |
| Classified as injury | 65.6% | 44.9% | 36.2% |
| Classified as malfunction | 32.4% | 52.5% | 62.3% |
| Filed by the manufacturer | 100% | 95.7% | 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 QZI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Farawave | 2,590 | 1,409 | 3.6% |
| PulseSelect | 2,146 | 1,266 | 0.8% |
| FARAWAVE Pulsed Field Ablation Catheter, 31mm | 863 | 85 | 1.4% |
| FARAWAVE Pulsed Field Ablation Catheter | 551 | 109 | 3.1% |
| FARAWAVE Nav | 527 | 404 | 3.2% |
| VARIPULSE Bi-Directional Catheter | 351 | 309 | 1.7% |
| Farawave PFA Catheter | 189 | 183 | 3.2% |
| FARADRIVE Steerable Sheath Clear | 4,154 | 1,559 | 0.5% |
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 Affera reports
How many FDA reports name Affera?
1,159 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 992 in the latest 12 months.
What kinds of events are reported?
injury (65.6%), malfunction (32.4%) and death (2.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device contamination with chemical or other material (9.9%), coagulation in device or device ingredient (2.4%), electromagnetic compatibility problem (1.6%), radiofrequency interference (rfi) (1.1%) and contamination (1%). 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 Affera 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.