Abbott Medical

• Armada™ 14 NC PTA Catheter Ref 2300550-100

  Class IIa EUDAMED Active

• Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Ref 1213275-18

  Class III EUDAMED Active

• EnSite™ Ref ENSITE-ECGRL-I-01

  Class I EUDAMED Active

• Armada™ 14 NC PTA Catheter Ref 2300450-020

  Class IIa EUDAMED Active

• Amulet™ Ref AMULET360-028

  Class III EUDAMED Active

• Armada™ 18 PTA Catheter Ref 1014261-120

  Class IIa EUDAMED Active

• Absolute Pro™ Peripheral Self-Expanding Stent System Ref 1012842-30

  Class IIb EUDAMED Active

• RX Herculink Elite™ Peripheral Stent System Ref 1011539-18

  Class IIb EUDAMED Active

• Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Ref 1213300-23

  Class III EUDAMED Active

• Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Ref 1213275-38

  Class III EUDAMED Active

• Current™ Ref PFA-GEN-OVERLAY

  Class I EUDAMED Active

• Armada™ 14 XT PTA Catheter Ref F2020-015

  Class IIa EUDAMED Active

• Armada™ 14 NC PTA Catheter Ref 2300450-060

  Class IIa EUDAMED Active

• Absolute Pro™ LL Peripheral Self-Expanding Stent System Ref 1013014-150

  Class IIb EUDAMED Active

• Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Ref 1213375-18

  Class III EUDAMED Active

• Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Ref 1213275-23

  Class III EUDAMED Active

• Armada™ 18 PTA Catheter Ref 1014260-100

  Class IIa EUDAMED Active

• Absolute Pro™ LL Peripheral Self-Expanding Stent System Ref 1012016-150

  Class IIb EUDAMED Active

• X.ACT™ Carotid Stent System Ref XRX02008S

  Class III EUDAMED Active

• Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Ref 1204300-15

  Class III EUDAMED Active

• MINI TREK™ Coronary Dilatation Catheter Ref 1012268-20

  Class III EUDAMED Active

• Armada™ 18 PTA Catheter Ref 1014258-060

  Class IIa EUDAMED Active

• Absolute Pro™ Peripheral Self-Expanding Stent System Ref 1012840-60

  Class IIb EUDAMED Active

• WorkMate Claris™ Ref H700167

  Class I EUDAMED Active

• Absolute Pro™ Peripheral Self-Expanding Stent System Ref 1011915-100

  Class IIb EUDAMED Active

• Armada™ 18 PTA Catheter Ref 1014255-200

  Class IIa EUDAMED Active

• Armada™ 18 PTA Catheter Ref 1014261-020

  Class IIa EUDAMED Active

• Armada™ 18 PTA Catheter Ref 1014257-180

  Class IIa EUDAMED Active

• WorkMate Claris™ Ref H701314

  Class I EUDAMED Active

• RX Herculink Elite™ Peripheral Stent System Ref 1011521-18

  Class IIb EUDAMED Active

• Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Ref 1213250-33

  Class III EUDAMED Active

• Absolute Pro™ Peripheral Self-Expanding Stent System Ref 1011925-040

  Class IIb EUDAMED Active

• RX Herculink Elite™ Peripheral Stent System Ref 1011530-12

  Class IIb EUDAMED Active

• Omnilink Elite™ Peripheral Stent System Ref 11011-29

  Class IIb EUDAMED Active

• Omnilink Elite™ Peripheral Stent System Ref 11003-39

  Class IIb EUDAMED Active

• Armada™ 18 PTA Catheter Ref 1014258-120

  Class IIa EUDAMED Active

• Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Ref 1204300-12

  Class III EUDAMED Active

• FemoStop™ Ref 11169

  Class I EUDAMED Active

• RX Herculink Elite™ Peripheral Stent System Ref 1011533-12

  Class IIb EUDAMED Active

• WorkMate Claris™ Ref H702089

  Class I EUDAMED Active

• Absolute Pro™ Peripheral Self-Expanding Stent System Ref 1011915-040

  Class IIb EUDAMED Active

• Armada™ 18 PTA Catheter Ref 1014254-200

  Class IIa EUDAMED Active

• Absolute Pro™ Peripheral Self-Expanding Stent System Ref 1012839-40

  Class IIb EUDAMED Active

• Absolute Pro™ Peripheral Self-Expanding Stent System Ref 1011923-060

  Class IIb EUDAMED Active

• Absolute Pro™ LL Peripheral Self-Expanding Stent System Ref 1012008-150

  Class IIb EUDAMED Active

• TactiSys™ Ref BED-CLP-WE

  Class I EUDAMED Active

• Absolute Pro™ Peripheral Self-Expanding Stent System Ref 1011914-020

  Class IIb EUDAMED Active

• Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Ref 2213250-76

  Class III EUDAMED Active

• Armada™ 18 PTA Catheter Ref 1014253-020

  Class IIa EUDAMED Active

• Armada™ 18 PTA Catheter Ref 1014258-150

  Class IIa EUDAMED Active

Showing the 10 most recent of 43 recalls.

• 2026

  • 12 May 2026 Z-2405-2026 Class II Ongoing Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

• 2025

  • 6 Oct 2025 Z-0458-2026 Class II Ongoing 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).
  • 6 Oct 2025 Z-0459-2026 Class II Ongoing 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).
  • 15 Feb 2025 Z-1557-2025 Class II Ongoing Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.

• 2024

  • 21 Nov 2024 Z-0753-2025 Class II Ongoing 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.
  • 17 Oct 2024 Z-0491-2025 Class II Ongoing 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.
  • 17 Oct 2024 Z-0492-2025 Class II Ongoing 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.
  • 17 Oct 2024 Z-0493-2025 Class II Ongoing 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.
  • 17 Oct 2024 Z-0494-2025 Class II Ongoing 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.
  • 17 Oct 2024 Z-0495-2025 Class II Ongoing 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.

• Abbott Medical Penang Pulau Pinang · MY FEI 3008377825
• Abbott Medical Saint Paul, MN · US FEI 3007113487

Country

United States

Address

2375, Morse Avenue, Irvine, California, United States

Website

abbott.com

Email

[email protected]

PRRC contact

Melissa Owsley

EUDAMED SRN

IE-MF-000002547

FDA FEI number

3006705815