Device manufacturer, as written on reports

Penumbra: medical device reports filed with FDA

21,617 reports name it as the manufacturer of the device involved, 2008–2026.

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.

21,617
reports naming it as manufacturer: 0.1% of all MAUDE reports; 441
reports, 12 months to August 2026: 436 in the 12 months before; 87.9%
classified as malfunction: 62.3% across all reports; 1.4%
classified as death, as reported: 0.9% across all reports

21,617 medical device reports received by FDA give Penumbra as the manufacturer of the device involved, 0.1% of the MAUDE database, from February 2008 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

441 reports arrived in the 12 months to August 2026, close to the 436 of 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 (87.9%), injury (10.6%) 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
Ruby Coil	Device, neurovascular embolization	3,359	26	0.1%
Penumbra Smart Coil	Device, neurovascular embolization	2,779	3	0.3%
Penumbra Coil 400	Device, neurovascular embolization	1,453	0	0.9%
POD Packing Coil	Device, neurovascular embolization	1,060	35	0%
Lantern Delivery Microcatheter	Catheter, percutaneous	887	19	0%
Ruby Coil Lp	Device, neurovascular embolization	479	13	0%
Penumbra System 3max Reperfusion Catheter	Catheter, thrombus retriever	473	0	3.1%
Indigo System Aspiration Catheter 6	Catheter, embolectomy	472	0	0%
Pod	Device, neurovascular embolization	405	18	0%
Neuron Max 6f 088 Long Sheath	Catheter, percutaneous	385	0	0.5%
Penumbra System Jet7 Reperfusion Catheter	Catheter, thrombus retriever	376	0	4%
Velocity Delivery Microcatheter	Catheter, percutaneous	336	21	0%
Penumbra System 5max Ace Reperfusion Catheter	Catheter, thrombus retriever	323	0	0.9%
Penumbra Smart Coil Detachment Handle	Device, neurovascular embolization	317	0	0%
Benchmark 6f 071 Delivery Catheter	Catheter, percutaneous	279	11	0.4%
Px Slim Delivery Microcatheter	Catheter, percutaneous	276	0	0.7%
Neuron Delivery Catheter 070	Catheter, percutaneous	271	0	0%
Indigo System Catrx Aspiration Catheter	—	255	11	0%
Packing Coil LP	Device, neurovascular embolization	235	11	0%
Indigo System Lightning 12	Peripheral mechanical thrombectomy with aspiration	217	0	3.2%
Penumbra System Ace 68 Reperfusion Catheter	Catheter, thrombus retriever	205	0	0%
Indigo System Aspiration Catheter 8	Catheter, embolectomy	192	2	1.5%
Penumbra System Reperfusion Catheter 032	Catheter, thrombus retriever	184	0	9.2%
Ruby Coil Detachment Handle	Device, neurovascular embolization	170	0	0%
Penumbra System RED 72 Reperfusion Catheter	Catheter, thrombus retriever	149	18	4.4%
Indigo System Separator 8	Catheter, embolectomy	148	4	1.9%

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	11,243	52%
NRY	Catheter, thrombus retriever	3,931	18.2%
DQY	Catheter, percutaneous	3,349	15.5%
DXE	Catheter, embolectomy	1,303	6%
QEW	Peripheral mechanical thrombectomy with aspiration	877	4.1%
JCX	Apparatus, suction, ward use, portable, ac-powered	251	1.2%
BTA	Pump, portable, aspiration (manual or powered)	203	0.9%
KRD	Device, vascular, for promoting embolization	145	0.7%
DQO	Catheter, intravascular, diagnostic	10	0%
DYB	Introducer, catheter	2	0%

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%298

Injury10.6%2,282

Malfunction87.9%18,991

Other0.2%39

Not given0%7

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

Questions about Penumbra reports

How many FDA device reports name Penumbra as manufacturer?

21,617 reports through August 2026, 441 of them in the latest 12 months.

Which of its brands appear most often?

Ruby Coil (3,359), Penumbra Smart Coil (2,779), Penumbra Coil 400 (1,453), POD Packing Coil (1,060) and Lantern Delivery Microcatheter (887).

Which device types does it report on?

device, neurovascular embolization (52%), catheter, thrombus retriever (18.2%), catheter, percutaneous (15.5%) and catheter, embolectomy (6%).

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.