HIGH

Medline Recalls St. Jude Electrophysiology Catheters Over Infection Risk

Medline Industries recalled reprocessed St. Jude electrophysiology catheters on December 22, 2025. The recall affects 48 units potentially contaminated with residual materials. The defective catheters pose a high risk of inflammation and systemic infection.

Quick Facts at a Glance

Recall Date
December 22, 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

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

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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About This Product

These diagnostic electrophysiology catheters are used in medical procedures to assess and treat heart conditions. They are critical in diagnosing arrhythmias and other cardiovascular issues.

Why This Is Dangerous

The risk stems from potential contamination with residual materials, which can provoke severe inflammatory responses and lead to systemic complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall poses a significant safety concern for patients undergoing electrophysiological procedures, necessitating immediate cessation of use and consultation with healthcare providers.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on your catheter against the recall list.
  2. Verify the lot number if available.
  3. If uncertain, contact your healthcare provider.

Where to find product info

Model and lot numbers are typically found on the packaging or the device itself.

What timeline to expect

Expect up to 6 weeks for refund processing after returning the product.

If the manufacturer is unresponsive

  • Document all communication attempts with Medline.
  • Reach out to the FDA or local health department for guidance.

How to prevent similar issues

  • Select single-use devices to avoid contamination risks.
  • Check for FDA clearance and recall history before purchase.
  • Consult healthcare providers for advice on safe products.

Documentation advice

Keep records of all communication, receipts, and photographs of the product.

Product Details

The recall includes various models of St. Jude Medical Supreme Diagnostic Electrophysiology Catheters. Models affected include 401211RH, 401222RH, 401223RH, among others. These were distributed nationwide in the U.S.

Key Facts

  • Recall affects 48 units of electrophysiology catheters
  • Potential contamination with residual materials
  • Risks include systemic infection and embolism complications
  • Stop using affected devices immediately
  • Contact Medline for further instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Classification

Product TypeDiagnostic Electrophysiology Catheter
Sold At
Multiple Retailers

Product Details

Model Numbers
401211RH UDI-DI 10197344043736 Lot EP250317
401222RH UDI-DI 10197344043712 Lot EP250317
401223RH UDI-DI 10197344043705 Lot EP250317
401226RH UDI-DI 10197344043699 Lot EP250307 EP250317
401227RH UDI-DI 10197344043682 Lots EP250307 EP250317
+15 more
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

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