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# FDA Flags Expanded Recall of Reprocessed Cardiac Catheters
- URL: https://www.fdaweb.com/fda-flags-expanded-recall-of-reprocessed-cardiac-catheters/
- Published: 2026-03-06T12:00:00.000Z
- Updated: 2026-09-14T13:35:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160775

FDA says an [expanded recall](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/catheter-recall-expansion-medline-industries-removes-reprocessed-electrophysiology-and-ultrasound?utm%5Fmedium=email&utm%5Fsource=govdelivery) by Medline Industries involving certain reprocessed electrophysiology and ultrasound catheters has been classified as Class 1, warning that the devices could cause serious injury or death if used.

The recall affects several catheters distributed through Medline’s ReNewal reprocessing program, including models originally manufactured by Abbott, Biosense Webster and Siemens Healthineers. The action expands a previously announced recall tied to potential contamination with small residual particles on the devices.

Affected products include electrophysiology and intracardiac ultrasound catheters such as the Livewire, Response and Supreme diagnostic electrophysiology catheters; the ViewFlex ultrasound catheter; the Inquiry electrophysiology catheter; the SoundStar ultrasound catheter; and the AcuNav ultrasound catheters in 8F and 10F sizes.

According to FDA, Medline notified customers in a letter dated Dec. 22 instructing them to immediately check inventory, quarantine affected products and destroy the devices after completing recall response actions. Healthcare providers and distributors were also told to notify downstream customers if the devices had been resold or transferred.

The company said certain lots of the reprocessed catheters may contain residual particulates on surfaces that come into contact with patients. If used, those particles could trigger inflammatory responses or systemic infection. In more severe scenarios, dislodged particles entering the bloodstream could lead to granulomatous reactions, thrombus formation, or serious complications such as cerebral or pulmonary embolism or deep vein thrombosis.

Electrophysiology diagnostic catheters are used in cardiac procedures to map electrical activity in the heart and help diagnose or treat arrhythmias.