Catheter, coronary, atherectomy: medical device reports filed with FDA

11,889 reports carry this product code, 1993–2026; 16 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.

11,889
reports with this product code: 0.1% of all MAUDE reports; 938
reports, 12 months to August 2026: 767 in the 12 months before; 55.3%
classified as malfunction: 62.3% across all reports; 7.4%
classified as death, as reported: 0.9% across all reports

Product code MCX is FDA's classification for "Catheter, coronary, atherectomy" (unknown panel), a class 3 device. 11,889 medical device reports carry this product code, 0.1% of the MAUDE database, from January 1993 to August 2026.

938 reports arrived in the 12 months to August 2026, up 22% from 767 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 (55.3%), injury (36.9%) and death (7.4%). 16 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
RotaLink? Plus	1,947	42	4.4%	69.7%
Rotablator Rotational Atherectomy System	1,917	88	7%	63.8%
Rotapro	1,565	313	4.7%	76%
Diamondback 360 Coronary Orbital Atherectomy System	1,501	0	15.7%	8.1%
RotaWire and wireClip Torquer	1,460	84	3.8%	65.3%
RotaLink Burr	627	39	8.1%	64.1%
Diamondback Coronary	491	222	15.9%	19.5%
ROTAWIRE Drive	369	85	3.5%	71%
AngioJet Ultra System Console	162	11	1.2%	95.1%
Rotalink Catheter	123	0	13%	35.7%
Rotablator Guide Wire	117	0	3.7%	55.7%
Diamondback 360 Peripheral Orbital Atherectomy System	4	0	0.9%	21.3%
AngioJet SOLENT omni	1	26	1.3%	93.1%
Diamondback 360 Orbital Atherectomy System	1	0	3.3%	4.6%
Selox JT 53	1	5	0%	54.7%
Synergy	1	84	3.5%	63.3%

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
Cardiovascular Systems	2,327	19.6%
Boston Scientific - Cork	1,763	14.8%
Boston Scientific - Costa Rica Heredia	591	5%
Boston Scientific - Costa Rica Coyol	517	4.3%
Boston Scientific - Fremont Ce	282	2.4%
Boston Scientific - Maple Grove	177	1.5%
Boston Scientific - Costa Rica	131	1.1%
Boston Scientific	87	0.7%
Abbott Vascular-Cardiac Therapies	74	0.6%
Guidant Vascular Intervention	54	0.5%
Boston Scientific - Fremont Sud	3	0%
Ev3	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

Death7.4%879

Injury36.9%4,392

Malfunction55.3%6,573

Other0.2%29

Not given0.1%16

Who filed

Manufacturer report96.4%11,457

Voluntary report1.3%158

User facility report0%0

Distributor report0%1

Not given2.3%273

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

Device problems coded

Device problem (FDA code)	Reports	Share
Entrapment of device	2,664	22.4%
Material separation	938	7.9%
Fracturea broken bone	833	7%
Detachment of device or device componentpart of the device came off	729	6.1%
Device damaged by another device	700	5.9%
Difficult to removethe device was hard to remove	662	5.6%
Output problem	576	4.8%
Failure to advance	313	2.6%
Device operates differently than expectedthe device behaved unexpectedly	288	2.4%
Breakthe device broke	276	2.3%
Detachment of device component	270	2.3%
No display/image	256	2.2%
Intermittent loss of power	238	2%
Material integrity problema problem with the device material	188	1.6%
Material deformation	187	1.6%
Mechanical problema mechanical problem	182	1.5%
Nonstandard device	168	1.4%
Difficult to advance	154	1.3%
Unintended system motionthe device moved when it should not have	154	1.3%
Device contamination with chemical or other material	150	1.3%

Questions about catheter, coronary, atherectomy reports

What is product code MCX?

FDA's classification code for "Catheter, coronary, atherectomy", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

11,889 reports through August 2026, 938 of them in the latest 12 months.

Which brands appear most often?

RotaLink? Plus (1,947), Rotablator Rotational Atherectomy System (1,917), Rotapro (1,565), Diamondback 360 Coronary Orbital Atherectomy System (1,501) and RotaWire and wireClip Torquer (1,460). 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.