FDA (Devices) recall action 97595
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Abbott is recalling 11,810 TactiFlex Sensor Enabled Ablation Catheters in the F-J curve after becoming aware of tip detachment events during removal from the packaging.
Abbott is recalling 407 TactiFlex Sensor Enabled Ablation Catheters in the UniD curve D configuration after becoming aware of tip detachment events during removal from the packaging.
Abbott is recalling 1,960 TactiFlex Sensor Enabled Ablation Catheters in the UniD curve F configuration after becoming aware of tip detachment events during removal from the packaging.
Abbott is recalling 3,404 TactiFlex Sensor Enabled Ablation Catheters in the D-D curve after becoming aware of tip detachment events during removal from the packaging.
Abbott is recalling 85,803 TactiFlex Sensor Enabled Ablation Catheters in the D-F curve after becoming aware of tip detachment events during removal from the packaging.