Device manufacturer, as written on reports

Boston Scientific: medical device reports filed with FDA

458,954 reports name it as the manufacturer of the device involved, 1992–2026.

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.

458,954
reports naming it as manufacturer: 1.8% of all MAUDE reports; 70,347
reports, 12 months to August 2026: 60,489 in the 12 months before; 46.2%
classified as malfunction: 62.3% across all reports; 1.5%
classified as death, as reported: 0.9% across all reports

458,954 medical device reports received by FDA give Boston Scientific as the manufacturer of the device involved, 1.8% of the MAUDE database, from January 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

70,347 reports arrived in the 12 months to August 2026, up 16% from 60,489 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 injury (52.1%), malfunction (46.2%) and death (1.5%). 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
Emblem Mri S-Icd	Implantable cardioverter defibrillator (non-crt)	21,406	3,088	0.2%
Ingevity Mri	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	17,085	1,749	0.3%
Emblem S-Icd	Implantable cardioverter defibrillator (non-crt)	15,921	2,237	0.1%
Ingevity+	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	15,340	2,150	0.3%
Reliance 4-Front	Implantable cardioverter defibrillator (non-crt)	9,793	2,024	0.4%
Taxus Express2 Paclitaxel-Eluting Coronary Stent System	Coronary drug-eluting stent	9,287	0	12.5%
AMS 800 Urinary Control System	Device, incontinence, mechanical/hydraulic	9,237	743	0%
AMS Inflatable Penile Prosthesis	Device, impotence, mechanical/hydraulic	9,074	687	0%
Endotak Reliance Sg	Permanent defibrillator electrodes	8,083	1,083	0.5%
Endotak Reliance G	Implantable cardioverter defibrillator (non-crt)	8,022	1,049	0.6%
AMS Inflatable Penile Prosthesis with Inhibizone	Device, impotence, mechanical/hydraulic	6,602	5	0%
Synergy	Coronary drug-eluting stent	5,258	84	3.5%
WOLVERINE Coronary Cutting Balloon MONORAIL	Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring	4,481	746	0.2%
Speedband Superview Super 7	Ligator, esophageal	4,474	640	0.2%
NC Emerge	Catheters, transluminal coronary angioplasty, percutaneous	4,473	543	1.4%
AMS 800 Urinary Control System with Inhibizone	Device, incontinence, mechanical/hydraulic	4,184	0	0%
Mustang	Stents, drains and dilators for the biliary ducts	3,524	491	0.3%
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System	System, appendage closure, left atrial	3,518	131	10.9%
Coyote? ES	Catheter, angioplasty, peripheral, transluminal	3,484	438	0%
FARADRIVE Steerable Sheath Clear	Catheter, steerable	3,347	1,559	0.5%
Ingevity +	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	3,006	2,281	0.6%
Teligen	Implantable pulse generator, pacemaker (non-crt)	2,831	47	0.6%
Ingenio	Implantable pulse generator, pacemaker (non-crt)	2,600	493	0.8%
Farawave	Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation	2,433	1,409	3.6%
WATCHMAN FLX? Pro	System, appendage closure, left atrial	2,302	1,386	12%
Sterling	Catheter, percutaneous	2,265	300	0.1%
Energen Icd	Implantable pulse generator, pacemaker (non-crt)	2,131	142	0.2%
WATCHMAN LAA Closure Device & Delivery System	System, appendage closure, left atrial	2,029	35	9.2%
2cm Peripheral Cutting Balloon	Catheter, angioplasty, peripheral, transluminal	1,969	314	0%
AMS 800 Artificial Urinary Sphincter	Device, incontinence, mechanical/hydraulic	1,935	1,149	0%

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
LWS	Implantable cardioverter defibrillator (non-crt)	71,350	15.5%
LWP	Implantable pulse generator, pacemaker (non-crt)	65,101	14.2%
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	37,025	8.1%
NIQ	Coronary drug-eluting stent	28,799	6.3%
EZY	Device, incontinence, mechanical/hydraulic	15,599	3.4%
FHW	Device, impotence, mechanical/hydraulic	15,391	3.4%
NVY	Permanent defibrillator electrodes	14,195	3.1%
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	12,359	2.7%
DTB	Permanent pacemaker electrode	9,504	2.1%
NGV	System, appendage closure, left atrial	9,038	2%

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

Death1.5%7,088

Injury52.1%239,124

Malfunction46.2%212,163

Other0.1%299

Not given0.1%280

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 reports

How many FDA device reports name Boston Scientific as manufacturer?

458,954 reports through August 2026, 70,347 of them in the latest 12 months.

Which of its brands appear most often?

Emblem Mri S-Icd (21,406), Ingevity Mri (17,085), Emblem S-Icd (15,921), Ingevity+ (15,340) and Reliance 4-Front (9,793).

Which device types does it report on?

implantable cardioverter defibrillator (non-crt) (15.5%), implantable pulse generator, pacemaker (non-crt) (14.2%), drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes (8.1%) and coronary drug-eluting stent (6.3%).

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.