Abbott has warned of damage that is occurring to some of its catheters during removal from packaging, leading to a safety alert being issued by the US Food and Drug Administration (FDA).
Abbott has recorded three cases of tip damage to its TactiFlex ablation catheter that occurred when users improperly removed the devices from the packaging tray. Although most damaged tips were noticed prior to surgery, three were not – the tips from these catheters detached and remained in the patient.
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There have been no injuries or deaths related to the issue as of 11 September. An 18 September FDA alert, part of a pilot programme to enhance medical device recall communications, said the agency is aware of a “potentially high-risk issue”.
The TactiFlex sensor-enabled ablation catheter is used for cardiac electrophysiological mapping during heart surgery and for the treatment of various abnormal heart rhythm disorders.
In all three cases Abbott reported, there were no adverse outcomes to patients. The medtech giant said it has made changes to the tray design to reduce the likelihood of tip damage during catheter removal, with the new packaging being recently deployed.
Tip detachment during cardiac procedures can cause embolisms or migration of the detached material. This could lead to not being able to breathe properly, blood flow issues, stroke, cardiac perforation, and vascular injury.
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By GlobalData“The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available,” the agency stated via its safety alert.
An Abbott spokesperson confirmed to Medical Device Network that no product is being removed from the market.
Tactiflex, which uses radiofrequency to ablate, was approved by the FDA in May 2023 for the treatment of atrial fibrillation. The device has helped spur sales in Abbott’s electrophysiology business to $2.5bn in 2024, though the modality is experiencing competition from pulsed field ablation (PFA). The technology is earmarked as an advancement over radiofrequency, thermal, and cryogenic-based ablation techniques due to its improved safety, although efficacy is consistent across the modalities.
