Device manufacturer, as written on reports

Boston Scientific - Marlborough: medical device reports filed with FDA

26,539 reports name it as the manufacturer of the device involved, 2009–2018.

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.

26,539
reports naming it as manufacturer: 0.1% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 27.4%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

26,539 medical device reports received by FDA give Boston Scientific - Marlborough as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 2009 to November 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 injury (72.4%), malfunction (27.4%) and death (0.2%). 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
Obtryx System	Mesh, surgical, polymeric	5,760	1	0%
Advantage? System	Mesh, surgical, polymeric	3,028	13	0%
Lynx System	Mesh, surgical, polymeric	2,056	9	0%
Resolution Clip Clipping Device	—	2,036	28	0.1%
Pinnacle Pelvic Floor Repair Kits	Mesh, surgical, polymeric	1,848	0	0.1%
Solyx SIS System	Mesh, surgical, polymeric	1,592	7	0.1%
Uphold Vaginal Support System	Mesh, surgical, polymeric	1,540	0	0.1%
Advantage Fit System	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	767	10	0.1%
Xenform Soft Tissue Repair Matrix	Mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed	685	0	0.1%
Uphold Lite	Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed	563	0	0%
Resolution 360 Clip	Hemostatic metal clip for the gi tract	555	385	0.2%
Resolution Hemostasis Clipping Device	Ligator, esophageal	549	0	1.5%
Flexiva Tm High Power Single-Use Laser Fiber	Powered laser surgical instrument	420	0	0.2%
Flexiva Tm Tractip High Power Single-Use Laser Fiber	Powered laser surgical instrument	391	0	0%
Hydro Thermablator Hta Endometrial Ablation System	Device, thermal ablation, endometrial	281	0	0%
Endostat 3 Bipolar/Monopolar Electrosurgical Generator	Unit, electrosurgical, endoscopic (with or without accessories)	231	0	0%
Endostat Electrosurgical Unit	Unit, electrosurgical, endoscopic (with or without accessories)	208	0	0%
Polyform Synthetic Mesh	Mesh, surgical, polymeric	202	0	0.2%
Accumaxtm Single Use Holmium Laser Fiber	Powered laser surgical instrument	200	0	0%
Resolution Clip Device	Ligator, esophageal	198	0	0.3%
Corflo Cubby Low Profile Gastrostomy Device	Tubes, gastrointestinal (and accessories)	166	0	0%
Pfr Kit Uphold Lite Vaginal Support System	Mesh, surgical, polymeric	133	0	0%
Hyrdothermablator Procedure Set	Device, thermal ablation, endometrial	126	0	0%
Upsylon	Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed	121	10	0%
Genesys Hta Procerva	Device, thermal ablation, endometrial	119	0	0%
Axios Stent And Delivery System	Pancreatic stent, covered, metallic, removable	118	0	4.3%
Rf3000 Radiofrequency Generator	Electrosurgical, cutting & coagulation & accessories	93	0	0%
Spyscope Ds Access & Delivery Catheter	Choledochoscope and accessories, flexible/rigid	80	0	0.1%
LightTrail Reusable	Powered laser surgical instrument	54	38	0%
EndoVive Safety PEG Kit	Tubes, gastrointestinal (and accessories)	51	23	0.8%

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
FTL	Mesh, surgical, polymeric	14,636	55.1%
OTP	Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed	1,819	6.9%
MND	Ligator, esophageal	1,538	5.8%
GEX	Powered laser surgical instrument	1,262	4.8%
OTN	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	995	3.7%
MNB	Device, thermal ablation, endometrial	699	2.6%
PAJ	Mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed	674	2.5%
PKL	Hemostatic metal clip for the gi tract	555	2.1%
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	529	2%
GEI	Electrosurgical, cutting & coagulation & accessories	298	1.1%

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

Death0.2%44

Injury72.4%19,223

Malfunction27.4%7,269

Other0%0

Not given0%3

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 - Marlborough reports

How many FDA device reports name Boston Scientific - Marlborough as manufacturer?

26,539 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Obtryx System (5,760), Advantage? System (3,028), Lynx System (2,056), Resolution Clip Clipping Device (2,036) and Pinnacle Pelvic Floor Repair Kits (1,848).

Which device types does it report on?

mesh, surgical, polymeric (55.1%), mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed (6.9%), ligator, esophageal (5.8%) and powered laser surgical instrument (4.8%).

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.