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Abbott FDA Recalls

15 recalls on file across devices, 6 of them Class I and 9 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheterClass ISep 10, 2025Abbott has become aware of a limited number of tip detachmen	Abbott has become aware of a limited number of tip detachment events during catheter removal from the packagin	Class IDevices	Sep 10, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheterClass ISep 10, 2025Abbott has become aware of a limited number of tip detachmen	Abbott has become aware of a limited number of tip detachment events during catheter removal from the packagin	Class IDevices	Sep 10, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheterClass ISep 10, 2025Abbott has become aware of a limited number of tip detachmen	Abbott has become aware of a limited number of tip detachment events during catheter removal from the packagin	Class IDevices	Sep 10, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheterClass ISep 10, 2025Abbott has become aware of a limited number of tip detachmen	Abbott has become aware of a limited number of tip detachment events during catheter removal from the packagin	Class IDevices	Sep 10, 2025
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheterClass ISep 10, 2025Abbott has become aware of a limited number of tip detachmen	Abbott has become aware of a limited number of tip detachment events during catheter removal from the packagin	Class IDevices	Sep 10, 2025
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080Class IIMar 17, 2025Device may have a small breach in the proximal end of the sh	Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system	Class IIDevices	Mar 17, 2025
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080Class IIMar 17, 2025Device may have a small breach in the proximal end of the sh	Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system	Class IIDevices	Mar 17, 2025
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generatorClass IISep 28, 2023Certain NT2000iX RF generators were serviced using a tool th	Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance a	Class IIDevices	Sep 28, 2023
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).Class IJun 12, 2023There is an overall reported incidence rate of 0.77% related	There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during pro	Class IDevices	Jun 12, 2023
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart Class IIJun 9, 2022When connected to the EnSite Precision Navigation System, an	When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Cathete	Class IIDevices	Jun 9, 2022
FIRMap" Catheter, 60mm BasketClass IIApr 28, 2022Incorrect product labeling.	Incorrect product labeling.	Class IIDevices	Apr 28, 2022
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.Class IIMar 24, 2022Devices were manufactured with a "First Use Date" preprogram	Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the si	Class IIDevices	Mar 24, 2022
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.Class IIMar 24, 2022Devices were manufactured with a "First Use Date" preprogram	Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the si	Class IIDevices	Mar 24, 2022
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MMClass IINov 16, 2021As a result of a manufacturing error, one (1) lot of Ultimum	As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured w	Class IIDevices	Nov 16, 2021
Amplatzer Steerable Delivery SheathClass IINov 9, 2021Instructions for use were updated.	Instructions for use were updated.	Class IIDevices	Nov 9, 2021

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