Abbott

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK9,889
• Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN7,022
• Permanent Defibrillator ElectrodesNVY6,475
• Implantable Pulse Generator, Pacemaker (Non-Crt)LWP5,894
• Implantable Cardioverter Defibrillator (Non-Crt)LWS3,344
• Pulse Generator, Permanent, ImplantableNVZ1,559
• Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)MXC1,552
• Leadless PacemakerPNJ721
• Implantable Pacemaker Pulse-GeneratorDXY679
• Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX523

Recent recalls

• 2026-06-11Open, ClassifiedSoftware Design Change

  Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

  Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

• 2026-04-29Open, ClassifiedProcess change control

  i-STAT EG7+ cartridge; List Number: 03P76-25;

  Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

• 2026-04-29Open, ClassifiedProcess change control

  i-STAT EG6+ cartridge; List Number: 03P77-25;

  Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

• 2026-04-29Open, ClassifiedProcess change control

  i-STAT G3+ cartridge; List Number: 03P78-26;

  Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.

• 2026-03-13Open, ClassifiedUnder Investigation by firm

  Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable

  It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

• 2026-01-14Open, ClassifiedProcess control

  FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

  Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

• 2026-01-14Open, ClassifiedProcess control

  FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

  Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

• 2026-01-14Open, ClassifiedProcess control

  FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

  Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

• 2026-01-14Open, ClassifiedProcess control

  FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.

  Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

• 2025-12-18Open, ClassifiedSoftware design

  Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

  Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.