Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter

510(k) K221067

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK221067	Date31 May 2023Cleared	StatusActive

3 recalls · 3 ongoing · FDA

- Ongoing Z-1321-2026 FDA Class I initiated 22 Dec 2025
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
- Ongoing Z-2610-2025 FDA Class I initiated 31 Jul 2025
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
- Ongoing Z-1460-2025 FDA Class II initiated 6 Feb 2025
Devices may have higher than expected amounts of bacterial endotoxin.

1 jurisdiction

United States — FDA 510(k) Active

510(k)