Device manufacturer, as written on reports

Abbott Medical: medical device reports filed with FDA

79,470 reports name it as the manufacturer of the device involved, 2015–2026.

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.

79,470
reports naming it as manufacturer: 0.3% of all MAUDE reports; 19,644
reports, 12 months to August 2026: 15,775 in the 12 months before; 21%
classified as malfunction: 62.3% across all reports; 2.4%
classified as death, as reported: 0.9% across all reports

79,470 medical device reports received by FDA give Abbott Medical as the manufacturer of the device involved, 0.3% of the MAUDE database, from February 2015 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

19,644 reports arrived in the 12 months to August 2026, up 25% from 15,775 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 (76.6%), malfunction (21%) and death (2.4%). 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
Kit Implantable Slim Tip Lead, 50cm	Dorsal root ganglion stimulator for pain relief	8,576	1,417	0.1%
Octrode Lead Kit, 60cm Length	Stimulator, spinal-cord, totally implanted for pain relief	4,271	5,133	0.1%
Proclaim 5 Elite Implantable Pulse Generator	Stimulator, spinal-cord, totally implanted for pain relief	3,394	2,057	0.1%
Mitraclip	Mitral valve repair devices	3,304	1,161	2%
Proclaim 7 Elite Implantable Pulse Generator	Stimulator, spinal-cord, totally implanted for pain relief	3,148	333	0.1%
Penta 3mm Lead, 60 cm	Stimulator, spinal-cord, totally implanted for pain relief	3,087	839	0.3%
Amplatzer Amulet	System, appendage closure, left atrial	2,537	591	12.3%
Eon Mini IPG, 16-Channel Rechargeable	Stimulator, spinal-cord, totally implanted for pain relief	2,507	111	0.2%
Navitor Vision	Aortic valve, prosthesis, percutaneously delivered	2,039	1,258	6.4%
MitraClip G4 Clip Delivery System (MDR)	Mitral valve repair devices	1,995	209	2.1%
Mitraclip G4 Clip Delivery System	Mitral valve repair devices	1,985	0	2.3%
Octrode Lead Kit, 90cm Length	Stimulator, spinal-cord, totally implanted for pain relief	1,821	329	0.2%
Amplatzer Septal Occluder	Transcatheter septal occluder	1,788	406	2.4%
Orion RC SCS IPG	Stimulator, spinal-cord, totally implanted for pain relief	1,761	861	0.3%
Proclaim DRG Implantable Pulse Generator	Dorsal root ganglion stimulator for pain relief	1,679	307	0.3%
Navitor Transcatheter Aortic Valve	Aortic valve, prosthesis, percutaneously delivered	1,379	245	9%
TriClip G4 System	Tricuspid valve repair device, percutaneously delivered	1,368	387	0.7%
Cardiomems Patient Electronic System	System, hemodynamic, implantable	1,219	738	0%
HF Sensor Delivery System	System, hemodynamic, implantable	1,192	757	4%
Mitraclip G4 Clip Delivery System Mdd	Mitral valve repair devices	1,180	0	3.2%
Swift-Lock Anchor	Stimulator, spinal-cord, implanted (pain relief)	1,128	206	0%
Kit Implantable Slim Tip Lead, 90cm	Dorsal root ganglion stimulator for pain relief	1,047	119	0.3%
MITRACLIP SYSTEM Clip Delivery System	Mitral valve repair devices	1,033	299	14.9%
MitraClip G5 Delivery System	Mitral valve repair devices	967	1,335	1.4%
Infinity 7 Implantable Pulse Generator	Stimulator, electrical, implanted, for parkinsonian tremor	914	147	0.5%
FlexNav Delivery System	Aortic valve, prosthesis, percutaneously delivered	647	244	4.2%
8CH Infinity DBS Flex Extn Kit, 50cm, B	Stimulator, electrical, implanted, for parkinsonian tremor	528	142	0%
Quattrode Lead Wide Spaced, 60 cm	Stimulator, spinal-cord, totally implanted for pain relief	506	143	0.1%
Protege IPG, 16-Channel Rechargeable	Stimulator, spinal-cord, totally implanted for pain relief	489	69	0.3%
CARDIOMEMS Power Supply	System, hemodynamic, implantable	471	350	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
LGW	Stimulator, spinal-cord, totally implanted for pain relief	26,317	33.1%
PMP	Dorsal root ganglion stimulator for pain relief	12,105	15.2%
NKM	Mitral valve repair devices	10,020	12.6%
NPT	Aortic valve, prosthesis, percutaneously delivered	4,788	6%
MOM	System, hemodynamic, implantable	3,411	4.3%
MLV	Transcatheter septal occluder	3,184	4%
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	3,000	3.8%
NGV	System, appendage closure, left atrial	2,288	2.9%
NPS	Tricuspid valve repair device, percutaneously delivered	1,966	2.5%
DYB	Introducer, catheter	1,760	2.2%

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

Death2.4%1,895

Injury76.6%60,886

Malfunction21%16,656

Other0%33

Not given0%0

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

Questions about Abbott Medical reports

How many FDA device reports name Abbott Medical as manufacturer?

79,470 reports through August 2026, 19,644 of them in the latest 12 months.

Which of its brands appear most often?

Kit Implantable Slim Tip Lead, 50cm (8,576), Octrode Lead Kit, 60cm Length (4,271), Proclaim 5 Elite Implantable Pulse Generator (3,394), Mitraclip (3,304) and Proclaim 7 Elite Implantable Pulse Generator (3,148).

Which device types does it report on?

stimulator, spinal-cord, totally implanted for pain relief (33.1%), dorsal root ganglion stimulator for pain relief (15.2%), mitral valve repair devices (12.6%) and aortic valve, prosthesis, percutaneously delivered (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.