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# FDA Warns on Paclitaxel-coated Devices’ Mortality Signal
- URL: https://www.fdaweb.com/fda-warns-on-paclitaxel-coated-devices-mortality-signal/
- Published: 2019-08-07T12:00:00.000Z
- Updated: 2026-09-15T01:42:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144709

FDA says that because of ongoing concerns about a late mortality signal in patients treated for peripheral artery disease in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents, it is working with manufacturers working on updated device labeling and clinical trial informed consent documents. In an [8/7 letter](https://www.fda.gov/medical-devices/letters-health-care-providers/august-7-2019-update-treatment-peripheral-arterial-disease-paclitaxel-coated-balloons-and-paclitaxel?utm%5Fcampaign=FDA%20MedWatch%20%2AUpdate%2A%20Paclitaxel-Coated%20Balloons%20and%20Paclitaxel-Eluting%20Stents&utm%5Fmedium=email&utm%5Fsource=Eloqua) to physicians, the agency says it is also continuing to push for additional clinical evidence development for assessing the long-term safety of paclitaxel-coated devices.

The letter comes on the heels of a 6/19-20 meeting ([see story](https://www.fdaweb.com/mortality-signal-with-paclitaxel-coated-devices/)) of the Circulatory System Devices Panel of the Medical Devices Advisory Committee that unanimously agreed data show a mortality signal. However, panel members were uncertain as to the signal’s magnitude, “primarily due to the small number of trials with five-years follow-up and high levels of missing data,” the agency said in a [summary of the meeting](https://www.fda.gov/media/128246/download?ref=fdaweb.com).

Additionally, the letter provides recommendations for health care providers, such as “diligent monitoring of patients who have been treated with paclitaxel-coated balloons and paclitaxel-eluting stents.” It also says for patients at “high risk for restenosis and repeat femoropopliteal interventions, clinicians may determine that the benefits of using a paclitaxel-coated device outweigh the risk of late mortality.”