Device manufacturer, as written on reports

Codman And Shurtleff: medical device reports filed with FDA

2,433 reports name it as the manufacturer of the device involved, 2003–2021.

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.

2,433
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 57.7%
classified as malfunction: 62.3% across all reports; 3.5%
classified as death, as reported: 0.9% across all reports

2,433 medical device reports received by FDA give Codman And Shurtleff as the manufacturer of the device involved, 0% of the MAUDE database, from September 2003 to November 2021. 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 (57.7%), injury (37.4%) and death (3.5%). 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
Enterprise Vascular Reconstruction Device And Delivery System	Intracranial neurovascular stent	537	0	7.6%
Orbit Galaxy Detachable Coil System	Device, neurovascular embolization	271	0	0.4%
Stent - Vascular Reconstruction	Intracranial neurovascular stent	252	3	9%
Xtrasoft Orbit Galaxy Detachable Coil	Device, neurovascular embolization	231	0	1.3%
Prowler Select Microcatheters	Catheter, continuous flush	163	0	1.5%
Trufill Dcs Orbit Mini Complex Fill	Device, neurovascular embolization	43	0	1.6%
Deltaplush - Cerecyte Microcoil	Device, neurovascular embolization	35	0	0.3%
Deltapaq - Cerecyte Microcoil	Device, neurovascular embolization	32	0	0%
Presidio 10 - Cerecyte Microcoil	Device, neurovascular embolization	32	0	1%
Trufill Dcs Orbit Detachable Coils Complex	Device, neurovascular embolization	27	0	0.8%
Presidio 18 - Cerecyte Microcoil	Device, neurovascular embolization	25	0	0%
Enterprise2 4mmx23mm	Intracranial neurovascular stent	20	1	0.5%
Prowler Select Plus 150/5cm	Catheter, continuous flush	16	1	0.2%
Codman	Drills, burrs, trephines & accessories (compound, powered)	6	0	1.6%
Hakim Programmable Valve	Shunt, central nervous system and components	3	9	0.9%
Codman Disposable Perforator	Drills, burrs, trephines & accessories (compound, powered)	2	0	0.2%
Neuromonitor Basic Kit	Device, monitoring, intracranial pressure	2	18	0.4%
Hakim Valve	Shunt, central nervous system and components	1	0	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
HCG	Device, neurovascular embolization	962	39.5%
NJE	Intracranial neurovascular stent	916	37.6%
KRA	Catheter, continuous flush	270	11.1%
KRD	Device, vascular, for promoting embolization	73	3%
DQY	Catheter, percutaneous	44	1.8%
JXG	Shunt, central nervous system and components	28	1.2%
LKK	Pump, infusion, implanted, programmable	26	1.1%
DQX	Wire, guide, catheter	8	0.3%
HBA	Neurosurgical paddie	8	0.3%
HBF	Drills, burrs, trephines & accessories (compound, powered)	8	0.3%

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

Death3.5%84

Injury37.4%911

Malfunction57.7%1,405

Other0%1

Not given1.3%32

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

Questions about Codman And Shurtleff reports

How many FDA device reports name Codman And Shurtleff as manufacturer?

2,433 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Enterprise Vascular Reconstruction Device And Delivery System (537), Orbit Galaxy Detachable Coil System (271), Stent - Vascular Reconstruction (252), Xtrasoft Orbit Galaxy Detachable Coil (231) and Prowler Select Microcatheters (163).

Which device types does it report on?

device, neurovascular embolization (39.5%), intracranial neurovascular stent (37.6%), catheter, continuous flush (11.1%) and device, vascular, for promoting embolization (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.