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

8,514 reports carry this product code, 1994–2026; 19 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.

8,514
reports with this product code: 0% of all MAUDE reports; 904
reports, 12 months to August 2026: 676 in the 12 months before; 55.6%
classified as malfunction: 62.3% across all reports; 1.8%
classified as death, as reported: 0.9% across all reports

Product code MCW is FDA's classification for "Catheter, peripheral, atherectomy" (cardiovascular panel), a class 2 device. 8,514 medical device reports carry this product code, 0% of the MAUDE database, from January 1994 to August 2026.

904 reports arrived in the 12 months to August 2026, up 34% from 676 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 (55.6%), injury (40.9%) and death (1.8%). 19 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
Rotarex	1,331	373	0.7%	84.6%
JETSTREAM XC Atherectomy Catheter	741	71	0.3%	79.2%
Diamondback 360 Peripheral Orbital Atherectomy System	672	0	0.9%	21.3%
Jetstream Xc	590	44	0%	89.3%
Hawkone 6fr	566	30	0%	71.9%
Diamondback 360 Orbital Atherectomy System	239	0	3.3%	4.6%
Peripheral Rotalink Plus	158	1	1.9%	74.7%
JETSTREAM Atherectomy Catheter	151	32	0.7%	27.8%
Crosser Recanalization Catheter	16	0	1.3%	81.8%
Rotalink Catheter	12	0	13%	35.7%
Diamondback 360 Coronary Orbital Atherectomy System	10	0	15.7%	8.1%
Crosser Cto Recanalization Catheter	9	0	0.3%	92%
Fogarty Arterial Embolectomy Catheter	4	37	0.2%	87.4%
Rotablator Guide Wire	2	0	3.7%	55.7%
Crosser Cto Recanalization Catheters	1	0	0%	93.7%
Datascope	1	0	7.3%	40.2%
Diamondback Coronary	1	222	15.9%	19.5%
RotaLink? Plus	1	42	4.4%	69.7%
Trapease Filter	1	0	13.9%	11.5%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Cardiovascular Systems	1,571	18.5%
Straub Medical	940	11%
Medtronic Ireland	873	10.3%
Spectranetics	322	3.8%
Ev3	301	3.5%
Boston Scientific - Cork	248	2.9%
Boston Scientific - Maple Grove	207	2.4%
The Spectranetics	135	1.6%
Covidien Irvine	115	1.4%
Bard Peripheral Vascular	47	0.6%
Boston Scientific	43	0.5%
Boston Scientific - Costa Rica Heredia	25	0.3%
Arrow Intl	24	0.3%
Guidant Vascular Intervention	8	0.1%
Boston Scientific - Fremont Ce	7	0.1%

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%150

Injury40.9%3,478

Malfunction55.6%4,733

Other1.5%131

Not given0.3%22

Who filed

Manufacturer report96.1%8,178

Voluntary report1.9%163

User facility report0%0

Distributor report0%2

Not given2%171

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,326	15.6%
Detachment of device or device componentpart of the device came off	1,120	13.2%
Entrapment of device	1,039	12.2%
Material separation	665	7.8%
Difficult to removethe device was hard to remove	602	7.1%
Material deformation	556	6.5%
Mechanical jam	442	5.2%
Physical resistance/sticking	324	3.8%
Mechanical problema mechanical problem	262	3.1%
Fracturea broken bone	240	2.8%
Suction problem	200	2.3%
Sticking	196	2.3%
Detachment of device component	194	2.3%
Difficult to advance	170	2%
Noise, audible	158	1.9%
Failure to advance	155	1.8%
Device damaged by another device	153	1.8%
Insufficient device problem information	153	1.8%
Device operates differently than expectedthe device behaved unexpectedly	125	1.5%
Aspiration issue	124	1.5%

Questions about catheter, peripheral, atherectomy reports

What is product code MCW?

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

How many reports carry this code?

8,514 reports through August 2026, 904 of them in the latest 12 months.

Which brands appear most often?

Rotarex (1,331), JETSTREAM XC Atherectomy Catheter (741), Diamondback 360 Peripheral Orbital Atherectomy System (672), Jetstream Xc (590) and Hawkone 6fr (566). 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.