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Abbott

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; c recall (Z-0109-2026)Abbott2025-10-10
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD recall (Z-0110-2026)Abbott2025-10-10
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF recall (Z-0111-2026)Abbott2025-10-10
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ recall (Z-0112-2026)Abbott2025-10-10
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; c recall (Z-0113-2026)Abbott2025-10-10
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 recall (Z-1643-2025)Abbott2025-04-21
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 recall (Z-1644-2025)Abbott2025-04-21
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator recall (Z-0209-2024)Abbott2023-11-02
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous cat recall (Z-2110-2023)Abbott2023-07-11
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE- recall (Z-1344-2022)Abbott2022-07-07
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage recall (Z-1220-2019)Abbott2019-04-25
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVA recall (Z-1774-2018)Abbott2018-05-17

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Every clearance here is in the API, with alerts when new ones post.