Catheter, steerable: medical device reports filed with FDA

13,946 reports carry this product code, 1992–2026; 20 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.

13,946
reports with this product code: 0.1% of all MAUDE reports; 2,648
reports, 12 months to August 2026: 3,908 in the 12 months before; 61.9%
classified as malfunction: 62.3% across all reports; 1.8%
classified as death, as reported: 0.9% across all reports

Product code DRA is FDA's classification for "Catheter, steerable" (cardiovascular panel), a class 2 device. 13,946 medical device reports carry this product code, 0.1% of the MAUDE database, from February 1992 to August 2026.

2,648 reports arrived in the 12 months to August 2026, down 32% from 3,908 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 (61.9%), injury (36.2%) and death (1.8%). 20 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
FARADRIVE Steerable Sheath Clear	4,151	1,559	0.5%	89.2%
FlexCath Advance Steerable Sheath	2,939	58	3.5%	45.4%
Mitraclip System Steerable Guide Catheter	1,527	16	3%	43%
G4 Steerable Guiding Catheter	896	0	1.6%	43.3%
FlexCath Contour Steerable Sheath	871	399	1.5%	62%
Faradrive	792	192	0.9%	78.2%
Mitraclip	753	1,161	2%	42.5%
Polarsheath	378	12	1.2%	68.9%
Flexcath Steerable Sheath	364	0	0.3%	67.9%
Steerable Guide Catheter	335	33	1.2%	38.1%
G4 Steerable Guiding Catheter Ce	262	2	1.1%	51.5%
FARADRIVE Steerable Sheath	192	102	4.2%	33.3%
Mitraclip G4 Steerable Guide Catheter Mdr	191	0	1.6%	45%
Heartlight	17	0	1%	6.8%
Artisan?	11	127	0.6%	13%
Arctic Front Advance Cardiac Cryoablation Catheter	8	46	2.6%	53.8%
Farawave	3	1,409	3.6%	53.6%
FARAWAVE Nav	1	404	3.2%	49.5%
MITRACLIP SYSTEM Clip Delivery System	1	299	14.9%	24.8%
Polarxfit	1	17	1.7%	65.1%

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
Boston Scientific	3,722	26.7%
Medtronic Cryocath	3,331	23.9%
Abbott Vascular	1,159	8.3%
Av-Temecula-Ct	1,138	8.2%
Abbott Medical	1,025	7.3%
Farapulse	885	6.3%
Medtronic Ireland	847	6.1%
Abbott Vascular-Cardiac Therapies	11	0.1%
St Jude Medical	7	0.1%
Greatbatch Medical	3	0%
Medtronic Perfusion Systems	2	0%
Biosense Webster	1	0%
Medtronic	1	0%
Medtronic Mexico S De R L De Cv	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

Death1.8%251

Injury36.2%5,052

Malfunction61.9%8,639

Other0%4

Not given0%0

Who filed

Manufacturer report99.3%13,850

Voluntary report0.4%61

User facility report0%0

Distributor report0%0

Not given0.3%35

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

Device problems coded

Device problem (FDA code)	Reports	Share
Air/gas in device	3,307	23.7%
Leak/splashthe device leaked	2,325	16.7%
Material twisted/bent	657	4.7%
Fluid/blood leak	604	4.3%
Gas/air leak	597	4.3%
Material integrity problema problem with the device material	520	3.7%
Device contamination with body fluid	417	3%
Air leak	404	2.9%
Nonstandard device	389	2.8%
Difficult to advance	250	1.8%
Breakthe device broke	246	1.8%
Deformation due to compressive stress	202	1.4%
Difficult to insertthe device was hard to insert	182	1.3%
Difficult to removethe device was hard to remove	152	1.1%
Suction problem	148	1.1%
Failure to advance	147	1.1%
Insufficient device problem information	143	1%
Improper or incorrect procedure or method	121	0.9%
Mechanical problema mechanical problem	120	0.9%
Positioning failure	120	0.9%

Questions about catheter, steerable reports

What is product code DRA?

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

How many reports carry this code?

13,946 reports through August 2026, 2,648 of them in the latest 12 months.

Which brands appear most often?

FARADRIVE Steerable Sheath Clear (4,151), FlexCath Advance Steerable Sheath (2,939), Mitraclip System Steerable Guide Catheter (1,527), G4 Steerable Guiding Catheter (896) and FlexCath Contour Steerable Sheath (871). 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.