FDA recall record · openFDA

Abbott

9 FDA recalls on record (2023–2025) — 9 device. 9 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. 5

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach i 2

Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefo 1

There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in 1

Recalls

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter Class I 2025-09-10 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter Class I 2025-09-10 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter Class I 2025-09-10 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter Class I 2025-09-10 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter Class I 2025-09-10 Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac). Class I 2023-06-12 Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 Class II 2025-03-17 Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 Class II 2025-03-17 Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator Class II 2023-09-28

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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