Device manufacturer, as written on reports
Abbott: medical device reports filed with FDA
43,473 reports name it as the manufacturer of the device involved, 1992–2026.
- 43,473
- reports naming it as manufacturer
- 0.2% of all MAUDE reports
- 3,929
- reports, 12 months to August 2026
- 5,673 in the 12 months before
- 62%
- classified as malfunction
- 62.3% across all reports
- 0.8%
- classified as death, as reported
- 0.9% across all reports
43,473 medical device reports received by FDA give Abbott as the manufacturer of the device involved, 0.2% of the MAUDE database, from June 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
3,929 reports arrived in the 12 months to August 2026, down 31% from 5,673 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 (62%), injury (37.1%) and death (0.8%). 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 |
|---|---|---|---|---|
| Tendril Sts | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 4,992 | 4,320 | 3.1% |
| Assurity Mri | Implantable pulse generator, pacemaker (non-crt) | 4,727 | 2,035 | 1.8% |
| Durata Sts Optim Active Fixation Df-4 Connector | Permanent defibrillator electrodes | 3,882 | 1,784 | 3.9% |
| Quadra Assura MP ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 2,614 | 507 | 2.1% |
| Gallant HF | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,648 | 1,918 | 0.7% |
| Isoflex Optim Lead | Permanent defibrillator electrodes | 1,237 | 437 | 2% |
| Quartet | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 1,209 | 848 | 5.2% |
| Confirm | Recorder, event, implantable cardiac, (without arrhythmia detection) | 1,072 | 34 | 0.1% |
| Alinity Ci-Series Level Sensor Bulk Solution | Analyzer, chemistry (photometric, discrete), for clinical use | 1,067 | 0 | 0% |
| Unify Assura ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 956 | 127 | 1.6% |
| Durata Sts Optim Active Fixation | Implantable cardioverter defibrillator (non-crt) | 779 | 301 | 5.6% |
| Quadra Assura ICD | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 751 | 67 | 0.8% |
| Endurity Mri | Implantable pulse generator, pacemaker (non-crt) | 710 | 159 | 1.2% |
| Tendril St | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 622 | 547 | 5.2% |
| Ellipse VR ICD, US | Implantable cardioverter defibrillator (non-crt) | 536 | 170 | 1.5% |
| Neutrino NxT HF | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 513 | 331 | 0.6% |
| Optisure Active Fixation Df-4 Connector | Permanent defibrillator electrodes | 511 | 623 | 4.3% |
| Aveir Leadless Pacemaker, Right Ventricle | Leadless pacemaker | 436 | 1,372 | 3.9% |
| Architect Havab Igm Reagent | Hepatitis a test (antibody and igm antibody) | 312 | 0 | 0% |
| Tendril Mri | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 311 | 422 | 4.1% |
| Optisense Lead | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 295 | 143 | 4.8% |
| Gallant VR | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 288 | 245 | 2% |
| Assert-IQ ICM | Recorder, event, implantable cardiac, (without arrhythmia detection) | 245 | 1,162 | 0% |
| Fortify Assura VR ICD, US | Implantable cardioverter defibrillator (non-crt) | 220 | 213 | 2.3% |
| Riata Passive Fixation | Permanent defibrillator electrodes | 218 | 32 | 1.2% |
| Alinity c Processing Module | Analyzer, chemistry (photometric, discrete), for clinical use | 212 | 302 | 0.1% |
| Jot Dx ICM | Recorder, event, implantable cardiac, (without arrhythmia detection) | 204 | 139 | 0.1% |
| Entrant HF | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 192 | 128 | 1.1% |
| Quartet Lead Small-S, 86 cm | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 163 | 159 | 2.1% |
| Fortify Vr U1 6 Sj4 Id | Implantable cardioverter defibrillator (non-crt) | 147 | 0 | 0.7% |
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 |
|---|---|---|---|
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) | 9,941 | 22.9% |
| NVN | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes | 7,056 | 16.2% |
| NVY | Permanent defibrillator electrodes | 6,513 | 15% |
| LWP | Implantable pulse generator, pacemaker (non-crt) | 5,905 | 13.6% |
| LWS | Implantable cardioverter defibrillator (non-crt) | 3,361 | 7.7% |
| NVZ | Pulse generator, permanent, implantable | 1,570 | 3.6% |
| MXC | Recorder, event, implantable cardiac, (without arrhythmia detection) | 1,564 | 3.6% |
| JJE | Analyzer, chemistry (photometric, discrete), for clinical use | 1,353 | 3.1% |
| PNJ | Leadless pacemaker | 692 | 1.6% |
| DXY | Implantable pacemaker pulse-generator | 559 | 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
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Abbott reports
How many FDA device reports name Abbott as manufacturer?
43,473 reports through August 2026, 3,929 of them in the latest 12 months.
Which of its brands appear most often?
Tendril Sts (4,992), Assurity Mri (4,727), Durata Sts Optim Active Fixation Df-4 Connector (3,882), Quadra Assura MP ICD (2,614) and Gallant HF (1,648).
Which device types does it report on?
defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) (22.9%), drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes (16.2%), permanent defibrillator electrodes (15%) and implantable pulse generator, pacemaker (non-crt) (13.6%).
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.