Reprocessed Livewire Electrophysiology Catheters Recalled for Residual Particulates
Reprocessed electrophysiology catheters may contain residual particulates, potentially causing infection, inflammation, blood clots, or embolism. The FDA classified this Class I recall affecting 7,913 units.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum Severe rating per the rubric. Although no reported illnesses or injuries are documented, the potential risks—systemic infection, blood clots, and embolism—present serious clinical consequences.
Plain-English summary
Medline Industries is recalling specific lots of reprocessed Livewire Steerable Electrophysiology Catheters distributed nationwide in the United States. The recall affects 7,913 units with lot numbers ranging from EP230724 through EP250108.
The catheters may contain small residual particulates on patient-contacting surfaces. If a device with residual particulates is used during electrophysiology procedures, there is a potential risk of inflammation or infection. If the particulates dislodge during the procedure and enter the bloodstream or come into contact with the heart, they may cause blood clots and potentially lead to stroke, pulmonary embolism, or deep vein thrombosis.
The FDA has classified this as a Class I recall, its most serious type. Healthcare facilities that received these devices should immediately stop using affected lot numbers and contact Medline Industries and the FDA for instructions on device replacement.
Patients who have undergone electrophysiology procedures should contact their healthcare provider with any concerns about whether an affected catheter was used.
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
- Hazard
- residual-particulates
- systemic-infection
- thrombosis
- embolism
- deep-vein-thrombosis
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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