Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600
Pending LLM rewrite. Source: FDA_DEVICE Z-2610-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Item Number/UDI (ea)/UDI(case): 401575RH 10888277407497 20888277407494
- 401582RH 10888277407510 20888277407517
- 401600RH 10888277407541 20888277407548
- 401603RH 10888277407558 20888277407555
- 401606RH 10888277407565 20888277407562
- 401652RH 10888277407572 20888277407579
- 401653RH 10888277407589 20888277407586
- 401654RH 10888277407596 20888277407593
- 401904RH 10888277407602 20888277407609
- 401905RH 10888277407619 20888277407616
- 401908RH 10197344020966 20197344020963
- 401914RH 10888277407527 20888177407524
- 401915RH 10888277407626 20888277407623
- 401918RH 10888277407640 20888277407647
- 401932RH 10888277407671 20888277407678
- 401933RH 10888277407688 20888277407685
- 401934RH 10888277407695 20888277407692
- 401938RH 10888277407701 20888277407708
- 401939RH 10888277407718 20888277407715
- 401940RH 10888277407480 20888277407487
Distribution
Distributed nationwide across the United States.
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