HIGH

Medline Industries Recalls Electrophysiology Catheters Over Infection Risk

Medline Industries recalled 7,913 reprocessed electrophysiology catheters on July 31, 2025. Residual particulates on patient-contacting surfaces pose a risk of serious infection and thrombus formation. Patients and healthcare providers must stop using these devices immediately.

Quick Facts at a Glance

Recall Date
July 31, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recall includes specific lots of reprocessed Livewire Steerable Electrophysiology Catheters. Item numbers affected include 401575RH, 401582RH, and numerous others. The devices were distributed nationwide in the United States.

The Hazard

Certain lots of these catheters may contain small residual particulates. If these particles dislodge during use, they can cause severe inflammatory responses or systemic infections.

Reported Incidents

There are no reported injuries or incidents linked to this recall at this time. However, the potential risks include cerebral or pulmonary embolism and deep vein thrombosis.

What to Do

Patients and healthcare providers should stop using these catheters immediately. Contact Medline Industries for further instructions and possible refunds.

Contact Information

For more information, call Medline Industries at 1-800-633-5463 or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2610-2025.

Key Facts

  • Recall date: July 31, 2025
  • Quantity recalled: 7,913
  • High hazard classification
  • Potential for serious health risks

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Item Number/UDI (ea)/UDI(case): 401575RH 10888277407497 20888277407494
401582RH 10888277407510 20888277407517
401600RH 10888277407541 20888277407548
401603RH 10888277407558 20888277407555
401606RH 10888277407565 20888277407562
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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