Abbott
7 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Abbott and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-22FDA-DeviceClass ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-22FDA-DeviceClass ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-22FDA-DeviceClass ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-22FDA-DeviceClass ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-10-22FDA-DeviceClass ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
- 2025-04-30FDA-DeviceClass IIAmplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
- 2025-04-30FDA-DeviceClass IIAmplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.
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