Device manufacturer, as written on reports

Boston Scientific - Costa Rica Coyol: medical device reports filed with FDA

7,680 reports name it as the manufacturer of the device involved, 2011–2018.

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.

7,680
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 71.7%
classified as malfunction: 62.3% across all reports; 1.4%
classified as death, as reported: 0.9% across all reports

7,680 medical device reports received by FDA give Boston Scientific - Costa Rica Coyol as the manufacturer of the device involved, 0% of the MAUDE database, from March 2011 to September 2018. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 (71.7%), injury (26.9%) and death (1.4%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Jagwire	Stylet for catheter, gastro-urology	751	22	0.7%
OptiCross	Catheter, ultrasound, intravascular	506	136	0.9%
Rotablator Rotational Atherectomy System	Catheter, coronary, atherectomy	439	88	7%
Rotatable Snare	Snare, flexible	280	20	0%
Ultrasonic Imaging Catheter - Coronary	Catheter, intravascular, diagnostic	273	0	0%
SENSATION Short Throw	Snare, flexible	256	83	0%
Capio SLIM	Holder, needle, gastroenterologic	240	61	0%
Captivator	Snare, flexible	227	29	0%
Captiflex	Snare, flexible	214	13	0%
Radial Jaw 4	Forceps, biopsy, non-electric	183	22	0.5%
Injection Gold Probe	Unit, electrosurgical, endoscopic (with or without accessories)	170	12	0.2%
Polaris? Ultra	Stent, ureteral	143	49	0%
Percuflex Plus	Stent, ureteral	140	50	0.4%
Flexima APDL	Tube, drainage, suprapubic	135	21	1.1%
Gold Probe	Unit, electrosurgical, endoscopic (with or without accessories)	122	15	0%
Flexima?	Stents, drains and dilators for the biliary ducts	102	10	0.4%
V-14 Controlwire	Wire, guide, catheter	92	0	0.3%
Amplatz Super Stiff Guidewire	Wire, guide, catheter	80	0	3%
Pt	Wire, guide, catheter	73	13	4%
Disposable Suture Placement System	Laparoscope, general & plastic surgery	72	0	0%
Endovive Jejunal Feeding Tube	Tubes, gastrointestinal (and accessories)	71	0	0.2%
V-18 Control Wire	Wire, guide, catheter	71	47	0.7%
Bone Anchor System For Soft Tissue Support	Fastener, fixation, nondegradable, soft tissue	67	0	0%
RotaWire and wireClip Torquer	Catheter, coronary, atherectomy	64	84	3.8%
Amplatz Super Stiff	Wire, guide, catheter	61	50	4.7%
Genesys Hta Procerva	Device, thermal ablation, endometrial	56	0	0%
Platinum Plus	Wire, guide, catheter	47	4	0%
EndoVive Standard PEG Kit	Tubes, gastrointestinal (and accessories)	45	15	2.1%
FilterWire EZ	Temporary coronary saphenous vein bypass graft for embolic protection	35	71	0.4%
V-14? Control Wire?	Wire, guide, catheter	34	25	0.3%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
FDI	Snare, flexible	1,214	15.8%
DQX	Wire, guide, catheter	906	11.8%
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	561	7.3%
MCX	Catheter, coronary, atherectomy	517	6.7%
OBJ	Catheter, ultrasound, intravascular	490	6.4%
EZB	Stylet for catheter, gastro-urology	463	6%
FGE	Stents, drains and dilators for the biliary ducts	428	5.6%
OCY	Endoscopic guidewire, gastroenterology-urology	374	4.9%
DQO	Catheter, intravascular, diagnostic	320	4.2%
FAD	Stent, ureteral	295	3.8%

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

Death1.4%108

Injury26.9%2,067

Malfunction71.7%5,503

Other0%0

Not given0%2

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Boston Scientific - Costa Rica Coyol reports

How many FDA device reports name Boston Scientific - Costa Rica Coyol as manufacturer?

7,680 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Jagwire (751), OptiCross (506), Rotablator Rotational Atherectomy System (439), Rotatable Snare (280) and Ultrasonic Imaging Catheter - Coronary (273).

Which device types does it report on?

snare, flexible (15.8%), wire, guide, catheter (11.8%), unit, electrosurgical, endoscopic (with or without accessories) (7.3%) and catheter, coronary, atherectomy (6.7%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.