Device manufacturer, as written on reports

Abbott Laboratories: medical device reports filed with FDA

19,183 reports name it as the manufacturer of the device involved, 1992–2026.

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.

19,183
reports naming it as manufacturer: 0.1% of all MAUDE reports; 838
reports, 12 months to August 2026: 867 in the 12 months before; 87.5%
classified as malfunction: 62.3% across all reports; 0.8%
classified as death, as reported: 0.9% across all reports

19,183 medical device reports received by FDA give Abbott Laboratories as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

838 reports arrived in the 12 months to August 2026, close to the 867 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 (87.5%), injury (6.6%) and other (4.2%). 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
Architect Ca 19-9xr	System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer	2,145	0	0%
Architect Reaction Vessel	Analyzer, chemistry (photometric, discrete), for clinical use	1,124	0	0%
Alinity c Processing Module	Analyzer, chemistry (photometric, discrete), for clinical use	1,045	302	0.1%
ARCHITECT STAT Troponin-I	Immunoassay method, troponin subunit	972	25	0.3%
Alinity i Processing Module	Analyzer, chemistry (photometric, discrete), for clinical use	763	219	0%
Lifecare Pca Plus Infuser	Pump, infusion, pca	581	0	6.9%
Architect C4000	Analyzer, chemistry (photometric, discrete), for clinical use	424	0	0%
Architect I2000sr	Analyzer, chemistry (photometric, discrete), for clinical use	423	0	0%
Lifecare Plum Pump Model 5000	Pump, infusion	368	0	0.9%
Axsym Rubella Igg Antibody	Enzyme linked immunoabsorbent assay, rubella	363	0	0%
Plum Xlm Single Chan	Pump, infusion	306	0	0.6%
Architect C16000	Analyzer, chemistry (photometric, discrete), for clinical use	304	0	0%
Acclaim Encore	Pump, infusion	303	0	0.2%
Prism Hcv	Assay, enzyme linked immunosorbent, hepatitis c virus	281	0	0%
Architect Stat Troponin-I Reagent Kit	Immunoassay method, troponin subunit	248	0	0%
Abbott Ambulatory Infusion-Aim Plus Pump	Pump, infusion	241	0	1.9%
Architect I1000sr	Analyzer, chemistry (photometric, discrete), for clinical use	239	0	0%
Architect C8000	Analyzer, chemistry (photometric, discrete), for clinical use	235	0	0%
Plum A+	Set, administration, intravascular	223	0	1.4%
Architect Cyclosporine	—	160	0	0%
Prism Hiv O Plus	Test, hiv detection	153	0	0%
Omni-Flow Model 4000 Plus	Pump, infusion	129	0	1.8%
Plum Xl Micro/Macro Pump	Pump, infusion	123	0	1.1%
Primary Plum Set With Conv Pin Sec Cap Port 1 Cl	Set, administration, intravascular	118	0	3.3%
Architect Bnp Calibrators	Calibrator, secondary	114	0	0%
Plum Xl3m Micro/Macro Pump	Pump, infusion	113	0	0.6%
Lifeshield Nv Primary Piggyback Set	Set, administration, intravascular	108	0	0.5%
Abbott	Set, administration, intravascular	106	0	7.5%
Alinity Ci-Series System Control Module	Analyzer, chemistry (photometric, discrete), for clinical use	91	12	0%
Architect Ipth	Radioimmunoassay, parathyroid hormone	69	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
JJE	Analyzer, chemistry (photometric, discrete), for clinical use	5,149	26.8%
FRN	Pump, infusion	2,670	13.9%
NIG	System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer	2,140	11.2%
FPA	Set, administration, intravascular	2,120	11.1%
MMI	Immunoassay method, troponin subunit	1,382	7.2%
MEA	Pump, infusion, pca	893	4.7%
LFX	Enzyme linked immunoabsorbent assay, rubella	376	2%
MZO	Assay, enzyme linked immunosorbent, hepatitis c virus	351	1.8%
GKZ	Counter, differential cell	311	1.6%
DRS	Transducer, blood-pressure, extravascular	245	1.3%

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

Death0.8%162

Injury6.6%1,266

Malfunction87.5%16,785

Other4.2%806

Not given0.9%164

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

Questions about Abbott Laboratories reports

How many FDA device reports name Abbott Laboratories as manufacturer?

19,183 reports through August 2026, 838 of them in the latest 12 months.

Which of its brands appear most often?

Architect Ca 19-9xr (2,145), Architect Reaction Vessel (1,124), Alinity c Processing Module (1,045), ARCHITECT STAT Troponin-I (972) and Alinity i Processing Module (763).

Which device types does it report on?

analyzer, chemistry (photometric, discrete), for clinical use (26.8%), pump, infusion (13.9%), system, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer (11.2%) and set, administration, intravascular (11.1%).

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.