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Reprocessed Livewire Steerable Electrophysiology Catheter recallZ-2610-2025 · Medline Industries, LP · initiated Jul 31, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On July 31, 2025, the firm notified customers via first class mail and email of the potential product issue. An updated letter was sent to customers on 8/13/25 with additional item and lot numbers. Affected products are to be returned for credit. Customers were instructed to immediately identify and quarantine all affected product within their possession. Once they have completed and returned the response form listing their affected inventory, they will receive return labels and RGA information. Customers will receive credit when the returned product is received.

Recall details

Recall number
Z-2610-2025
Status
Open, Classified
Initiated by the company
Jul 31, 2025
Posted by the FDA
Sep 26, 2025
Recalling firm
Medline Industries, LP
Quantity
7913 eaches
Product code
NLH
FDA submissions
K221067
Distribution
Domestic US distribution nationwide. International distribution pending. No international distribution.

Product description

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 401941RH 401991RH

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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; 401941RH 10888277407725 20888277407722; 401991RH 10888277407756 2088277407753; LOTS EP230724 EP230731 EP230803 EP230816 EP230914 EP231017 EP231116 EP240108 EP240122 EP240212 EP240227 EP240311 EP240322 EP240411 EP240415 EP240422 EP240429 EP240507 EP240514 EP240520 EP240528 EP240607 EP240611 EP240710 EP240715 EP240723 EP240805 EP240812 EP240820 EP240829 EP240911 EP240923 EP240930 EP241008 EP241030 EP241125 EP250108

Devices named in this recall

22 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

10 devices cleared under K221067 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97496).

Sources and updates

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