Reprocessed steerable electrophysiology catheters recalled over residual particulates on surfaces
Medline is recalling 7,913 reprocessed Livewire Steerable Electrophysiology Catheters because specific lots may carry small residual particulates on patient-contacting surfaces.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.
Plain-English summary
Reprocessed Livewire Steerable Electrophysiology Catheters are being recalled. The devices carry Medline item numbers including 401575RH, 401582RH, 401600RH, 401603RH, 401606RH, 401652RH, 401653RH, 401654RH, 401904RH, 401905RH, 401908RH, 401914RH, 401915RH, 401918RH, 401932RH, 401933RH and 401934RH.
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If a device with residual particulates on patient-contacting surfaces is used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood 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 recall covers 7,913 units distributed nationwide in the United States. The FDA has classified the recall as Class I.
Electrophysiology labs should identify affected lots by item number and UDI and follow Medline's instructions for returning or quarantining stock.
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…
- Manufacturer
- Medline Industries, LP
- Affected units
- 7,913
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.
Part of a larger recall action
This product is one of 5 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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