Official recall record
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-07-31
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10888277407497
- Brand on record
- Medline Industries, LP
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-08-14 · US FDA — Medical Devices
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medica - 2026-08-14 · US FDA — Medical Devices
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended for me - 2026-08-14 · US FDA — Medical Devices
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/
All 257 official recall notices naming Medline Industries, LP on this site →