Device manufacturer, as written on reports

Boston Scientific - Spencer: medical device reports filed with FDA

10,997 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.

10,997
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 72.8%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

10,997 medical device reports received by FDA give Boston Scientific - Spencer as the manufacturer of the device involved, 0% of the MAUDE database, from April 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 malfunction (72.8%), injury (26.7%) and death (0.5%). 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
Speedband Superview Super 7	Ligator, esophageal	1,266	640	0.2%
Spyscope Ds Access & Delivery Catheter	Choledochoscope and accessories, flexible/rigid	692	0	0.1%
Trapezoid RX	Lithotriptor, biliary mechanical	532	132	0.3%
Prefyx Pps System	Mesh, surgical, polymeric	461	0	0.2%
Biliary Stent Biliary Stent System Biliary Endoprosthesis	Stents, drains and dilators for the biliary ducts	318	0	0%
Endovive Jejunal Feeding Tube	Tubes, gastrointestinal (and accessories)	307	0	0.2%
Endovive Initial Placement Peg Kit Direct Pej Kit And Peg Safety Kit	Tubes, gastrointestinal (and accessories)	297	0	0.9%
EndoVive Standard PEG Kit	Tubes, gastrointestinal (and accessories)	288	15	2.1%
EndoVive Safety PEG Kit	Tubes, gastrointestinal (and accessories)	280	23	0.8%
RX Cytology Brush	Endoscopic cytology brush	255	5	0.8%
Advanix Biliary	Stents, drains and dilators for the biliary ducts	250	75	0.9%
Bone Anchor System For Soft Tissue Support	Fastener, fixation, nondegradable, soft tissue	248	0	0%
Flexima Biliary	Stents, drains and dilators for the biliary ducts	235	34	0%
Endovive Two-Port Ttp Jejunal Feeding Tube Cap	Tubes, gastrointestinal (and accessories)	230	0	1.5%
Interject	Biopsy needle	197	8	0.4%
Trapezoid Rx Lithotripter Compatible Basket Models 1086 1087 1088	Lithotriptor, biliary mechanical	176	0	0%
Hydratome Rx Sphincterotome	Unit, electrosurgical, endoscopic (with or without accessories)	141	0	0.2%
Genesys Hta Procerva	Device, thermal ablation, endometrial	139	0	0%
Autotome Rx Sphincterotome	Unit, electrosurgical, endoscopic (with or without accessories)	137	0	0.5%
Zero Tip	Dislodger, stone, basket, ureteral, metal	127	44	0%
Endovive Securi-T	Tubes, gastrointestinal (and accessories)	120	0	0.4%
Rx Biliary	Stents, drains and dilators for the biliary ducts	119	5	0%
Hydratome RX 44	Unit, electrosurgical, endoscopic (with or without accessories)	99	10	0%
Leveen Coaccess	Electrosurgical, cutting & coagulation & accessories	86	0	3.7%
Dreamtome RX 44	Unit, electrosurgical, endoscopic (with or without accessories)	76	34	0.5%
Autotome RX 44	Unit, electrosurgical, endoscopic (with or without accessories)	73	62	0.2%
Advanix? Pancreatic Stent	Stents, drains and dilators for the biliary ducts	68	18	0%
Flexima Catheter	Tube, drainage, suprapubic	62	0	1.9%
Leveen Needle Electrode	Electrosurgical, cutting & coagulation & accessories	62	0	1.9%
Stonetome	Dislodger, stone, biliary	61	22	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
KNT	Tubes, gastrointestinal (and accessories)	1,781	16.2%
FGE	Stents, drains and dilators for the biliary ducts	1,344	12.2%
FHN	Ligator, hemorrhoidal	1,037	9.4%
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	931	8.5%
LQC	Lithotriptor, biliary mechanical	712	6.5%
FBN	Choledochoscope and accessories, flexible/rigid	692	6.3%
FFL	Dislodger, stone, basket, ureteral, metal	556	5.1%
MND	Ligator, esophageal	455	4.1%
FTL	Mesh, surgical, polymeric	444	4%
GEI	Electrosurgical, cutting & coagulation & accessories	351	3.2%

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

Death0.5%51

Injury26.7%2,936

Malfunction72.8%8,006

Other0%0

Not given0%4

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 - Spencer reports

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

10,997 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Speedband Superview Super 7 (1,266), Spyscope Ds Access & Delivery Catheter (692), Trapezoid RX (532), Prefyx Pps System (461) and Biliary Stent Biliary Stent System Biliary Endoprosthesis (318).

Which device types does it report on?

tubes, gastrointestinal (and accessories) (16.2%), stents, drains and dilators for the biliary ducts (12.2%), ligator, hemorrhoidal (9.4%) and unit, electrosurgical, endoscopic (with or without accessories) (8.5%).

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.