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Abbott Medical

FDA Regulatory Profile

Abbott Medical appears in FDA public data with 43 recalls — including 7 Class I (most serious) —, 59 510(k) clearances, 53 FDA inspections, and 5 compliance actions on record. Its most recent recall (Z-2405-2026, Class II) was initiated on May 12, 2026. Its most recent 510(k) clearance was granted on July 15, 2026.

Summary

Total Recalls
43 (7 Class I)
510(k) Clearances
59
Inspections
53
Compliance Actions
5

Recent Recalls

NumberClassProductDate
Z-2405-2026Class IIMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 softwareMay 12, 2026
Z-0458-2026Class IIEterna SCS IPG (Implantable Pulse Generator), Model Number 32400October 6, 2025
Z-0459-2026Class IILiberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400October 6, 2025
Z-1557-2025Class IIAveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REFFebruary 15, 2025
Z-0753-2025Class IIThe Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedNovember 21, 2024
Z-0491-2025Class IIAbbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, SterileOctober 17, 2024
Z-0492-2025Class IIAbbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, SterileOctober 17, 2024
Z-0495-2025Class IIAbbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, SterileOctober 17, 2024
Z-0493-2025Class IIAbbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, SterileOctober 17, 2024
Z-0494-2025Class IIAbbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, SterileOctober 17, 2024
Z-0551-2025Class IIIMerlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stoOctober 1, 2024
Z-0552-2025Class IIIMerlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOctober 1, 2024
Z-2431-2024Class IIAbbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx OnlyMay 22, 2024
Z-2432-2024Class IIAbbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx OnlyMay 22, 2024
Z-2430-2024Class IIAbbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx OnlyMay 22, 2024
Z-2429-2024Class IIAbbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx OnlyMay 22, 2024
Z-2363-2024Class IIAbbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx OnlyMay 16, 2024
Z-2369-2024Class IIProclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyMay 16, 2024
Z-2362-2024Class IIAbbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx OnlyMay 16, 2024
Z-2364-2024Class IIAbbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx OnlyMay 16, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K262006EnSite™ X EP SystemJuly 15, 2026
K261631Amplatzer TorqVue Exchange SystemJune 17, 2026
K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon April 24, 2026
K260212EnSite™ X EP SystemApril 20, 2026
K253907Disposable Radiofrequency CannulaApril 16, 2026
K260499Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F4March 13, 2026
K252512Armada™ 14 NC PTA CatheterFebruary 13, 2026
K253516Assert-IQ (DM5100)December 18, 2025
K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)December 17, 2025
K253232Seguin Annuloplasty RingOctober 29, 2025
K250031Amplatzer GuidewireOctober 3, 2025
K252013EnSite™ X EP SystemSeptember 25, 2025
K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark September 4, 2025
K251234EnSite™ X EP SystemJuly 30, 2025
K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireJuly 25, 2025
K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)May 27, 2025
K251211ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping CathetMay 23, 2025
K251231ViewFlex™ X ICE Catheter, Sensor Enabled™May 20, 2025
K250426Amulet™ Steerable Delivery SheathApril 25, 2025
K243549JETi Hydrodynamic Thrombectomy SystemApril 4, 2025

FDA data resources