Abbott Medical

Reports per year

Source: FDA adverse event reports by year received, 2002–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW25,680
• Dorsal Root Ganglion Stimulator For Pain ReliefPMP11,750
• Mitral Valve Repair DevicesNKM9,596
• Aortic Valve, Prosthesis, Percutaneously DeliveredNPT4,476
• Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY3,252
• Transcatheter Septal OccluderMLV3,079
• System, Hemodynamic, ImplantableMOM2,922
• System, Appendage Closure, Left AtrialNGV2,554
• Tricuspid Valve Repair Device, Percutaneously DeliveredNPS1,793
• Heart-Valve, Non-Allograft TissueLWR1,694

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.

• 2025-11-07Open, ClassifiedProcess control

  Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400

  There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

• 2025-11-07Open, ClassifiedProcess control

  Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400

  There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

• 2025-04-14Open, ClassifiedProcess control

  Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.

  Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.

• 2024-12-23Open, ClassifiedUnder Investigation by firm

  The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

  Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.

• 2024-11-26Open, ClassifiedSoftware design

  Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.

  Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

• 2024-11-26Open, ClassifiedSoftware design

  Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN

  Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

• 2024-11-20Open, ClassifiedUnder Investigation by firm

  Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile

  A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

• 2024-11-20Open, ClassifiedUnder Investigation by firm

  Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile

  A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.

• 2024-11-20Open, ClassifiedUnder Investigation by firm

  Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile

  A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.