Abbott
Abbott holds FDA 510(k) medical device clearances, first cleared 2018, most recent 2026, with 19 FDA device recalls on record.
Top product codes for Abbott
FDA recalls by Abbott
10 most recent of 19- Z-0110-2026 — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
- Z-0111-2026 — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
- Z-0109-2026 — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
- Z-0113-2026 — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
- Z-0112-2026 — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
- Z-1644-2025 — Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
- Z-1643-2025 — Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
- Z-0209-2024 — Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
- Z-2110-2023 — Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
- Z-1344-2022 — Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Abbott
- K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
- K260993 — Amplatzer TorqVue Delivery System
- K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
- K233655 — Lingo Glucose System
- K222297 — CentriMag Pre-connected Pack
- K221213 — EnSite X EP System
- K212061 — EnSite X EP System
- K210392 — WorkMate Claris System
- K192593 — Confirm Rx Insertable Cardiac Monitor
- K190167 — MitraClip G4 Steerable Guide Catheter
- K182981 — Confirm Rx Insertable Cardiac Monitor
- K183128 — EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
- K182644 — EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
Data sourced from openFDA. This site is unofficial and independent of the FDA.