Catheter, electrode recording, or probe, electrode recording: medical device reports filed with FDA

8,781 reports carry this product code, 1992–2026; 27 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

8,781
reports with this product code: 0% of all MAUDE reports; 406
reports, 12 months to August 2026: 535 in the 12 months before; 48.8%
classified as malfunction: 62.3% across all reports; 3.5%
classified as death, as reported: 0.9% across all reports

Product code DRF is FDA's classification for "Catheter, electrode recording, or probe, electrode recording" (cardiovascular panel), a class 2 device. 8,781 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

406 reports arrived in the 12 months to August 2026, down 24% from 535 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 malfunction (48.8%), injury (47.1%) and death (3.5%). 27 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Achieve Mapping Catheter - 20 mm	1,171	82	3.1%	60.6%
Achieve Mapping Catheter	645	0	4.7%	36.4%
Advisor HD Grid Mapping Catheter, Sensor Enabled	454	32	3.3%	53.8%
Intellamap Orion High Resolution Mapping Catheter	386	0	4.1%	38.1%
Achieve Advance Mapping Catheter	361	34	4.4%	44.6%
IntellaMap Orion	261	52	0.8%	54.8%
Lasso 2515 Nav Eco Variable Catheter	231	0	0.4%	68.4%
Inquiry Steerable Diagnostic Catheter	228	8	3.9%	24.9%
Stockert 70 Rf Generator	197	0	4.2%	33.5%
Lasso 2515 Nav Variable Catheter	188	0	0.5%	86.7%
Navistar Electrophysiology Catheter	165	0	6%	19.6%
Decanav Electrophysiology Catheter	152	4	3.3%	32.7%
NaviStar ThermoCool	43	20	7%	21%
Polarsheath	36	12	1.2%	68.9%
Viking	36	1	5%	49.7%
QDOT Micro	27	390	3%	54.3%
Thermocool Smarttouch Uni-Directional Navigation Catheter	14	0	4.1%	34.1%
Qdot Micro Catheter	6	37	3.5%	61.3%
Therapy Ablation Catheter	3	7	0.5%	63.2%
Thermocool Sf Nav Uni-Directional Catheter	2	0	4.1%	17.8%
Thermocool Smarttouch Bi-Directional Navigation Catheter	2	0	5%	29%
Thermocool Smarttouch Sf Bi-Directional Nav Catheter	2	0	3.4%	31.6%
Navi-Star Thermo-Cool Electrophysiology Catheter	1	2	1.9%	53.7%
Navistar Rmt Thermocool Electrophysiology Catheter	1	0	7.1%	18.2%
Polarcath	1	0	3.7%	34.1%
Steerable Guide Catheter	1	33	1.2%	38.1%
ThermoCool SmartTouch	1	100	2.6%	63.6%

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	1,459	16.6%
St Jude Medical	1,155	13.2%
Medtronic Mexico S De R L De Cv	943	10.7%
Biosense Webster Juarez	725	8.3%
Medtronic Mexico	553	6.3%
Biosense Webster Irwindale	385	4.4%
Medtronic Cryocath	234	2.7%
Boston Scientific - Costa Rica Heredia	153	1.7%
St Jude Medical Costa Rica Ltda	91	1%
Medtronic	46	0.5%
Arrow Intl	4	0%
C R Bard	4	0%
Medtronic Vascular	4	0%
Arrow International	2	0%
Bard	2	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

Death3.5%308

Injury47.1%4,137

Malfunction48.8%4,283

Other0.4%38

Not given0.2%15

Who filed

Manufacturer report94.8%8,325

Voluntary report1.2%102

User facility report0%0

Distributor report0%3

Not given4%351

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Material twisted/bent	821	9.3%
Patient device interaction problem	414	4.7%
Insufficient device problem information	398	4.5%
Material deformation	382	4.4%
Entrapment of device	319	3.6%
Difficult to removethe device was hard to remove	296	3.4%
Breakthe device broke	266	3%
Material integrity problema problem with the device material	199	2.3%
Device operates differently than expectedthe device behaved unexpectedly	187	2.1%
Device displays incorrect message	167	1.9%
Material separation	155	1.8%
Signal artifact/noise	148	1.7%
Fracturea broken bone	146	1.7%
Device contamination with chemical or other material	129	1.5%
Sticking	117	1.3%
Replace	113	1.3%
Communication or transmission problemthe device could not communicate or transmit	109	1.2%
Detachment of device or device componentpart of the device came off	93	1.1%
Positioning problem	92	1%
Mechanical problema mechanical problem	91	1%

Questions about catheter, electrode recording, or probe, electrode recording reports

What is product code DRF?

FDA's classification code for "Catheter, electrode recording, or probe, electrode recording", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

8,781 reports through August 2026, 406 of them in the latest 12 months.

Which brands appear most often?

Achieve Mapping Catheter - 20 mm (1,171), Achieve Mapping Catheter (645), Advisor HD Grid Mapping Catheter, Sensor Enabled (454), Intellamap Orion High Resolution Mapping Catheter (386) and Achieve Advance Mapping Catheter (361). 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.