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FDA product code LPB · class 3 · Unknown
Cardiac ablation percutaneous catheter: medical device reports filed with FDA
16,527 reports carry this product code, 1992–2026; 30 brands with a page.
- 16,527
- reports with this product code
- 0.1% of all MAUDE reports
- 1,067
- reports, 12 months to August 2026
- 1,525 in the 12 months before
- 37%
- classified as malfunction
- 62.3% across all reports
- 4.4%
- classified as death, as reported
- 0.9% across all reports
Product code LPB is FDA's classification for "Cardiac ablation percutaneous catheter" (unknown panel), a class 3 device. 16,527 medical device reports carry this product code, 0.1% of the MAUDE database, from December 1992 to August 2026.
1,067 reports arrived in the 12 months to August 2026, down 30% from 1,525 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 (58.2%), malfunction (37%) and death (4.4%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Biosense Webster | 10,656 | 64.5% |
| Biosense Webster Juarez | 2,828 | 17.1% |
| Biosense Webster Irwindale | 897 | 5.4% |
| Medtronic Cryocath | 401 | 2.4% |
| St Jude Medical | 92 | 0.6% |
| Medtronic Milaca | 62 | 0.4% |
| Boston Scientific - Costa Rica Heredia | 36 | 0.2% |
| Mpri | 18 | 0.1% |
| Medtronic Puerto Rico | 11 | 0.1% |
| Plexus Manufacturing Sdn Bhd | 5 | 0% |
| Medtronic Neuromodulation | 4 | 0% |
| Medtronic Mexico | 3 | 0% |
| Atricure | 1 | 0% |
| Covidien Shanghai | 1 | 0% |
| Lifescan | 1 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Patient device interaction problem | 3,940 | 23.8% |
| Insufficient device problem information | 1,075 | 6.5% |
| Material puncture/hole | 676 | 4.1% |
| Incorrect, inadequate or imprecise result or readings | 593 | 3.6% |
| Contamination /decontamination problem | 483 | 2.9% |
| Failure to sense | 469 | 2.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 423 | 2.6% |
| Device displays incorrect message | 375 | 2.3% |
| Obstruction of flow | 368 | 2.2% |
| High readingsreadings were too high | 351 | 2.1% |
| Signal artifact/noise | 320 | 1.9% |
| Temperature problem | 262 | 1.6% |
| Coagulation in device or device ingredient | 259 | 1.6% |
| Breakthe device broke | 242 | 1.5% |
| Device contamination with body fluid | 233 | 1.4% |
| Device contamination with chemical or other material | 211 | 1.3% |
| Positioning problem | 208 | 1.3% |
| Insufficient cooling | 204 | 1.2% |
| Charred | 168 | 1% |
| Communication or transmission problemthe device could not communicate or transmit | 157 | 0.9% |
Questions about cardiac ablation percutaneous catheter reports
What is product code LPB?
FDA's classification code for "Cardiac ablation percutaneous catheter", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
16,527 reports through August 2026, 1,067 of them in the latest 12 months.
Which brands appear most often?
Thermocool Smart Touch Sf Bi-Directional Navigation Catheter (4,533), ThermoCool SmartTouch SF (1,721), Thermocool Smarttouch Bi-Directional Navigation Catheter (1,204), Thermocool Smart Touch Sf Uni-Directional Navigation Catheter (878) and Thermocool Smart Touch Electrophysiology Catheter (707). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.