Medline Industries, LP is recalling 7,913 reprocessed ViewFlex Xtra ICE Catheters distributed nationwide in the United States. The lots may contain small residual particulates on patient-contacting surfaces. Healthcare providers and patients should stop using the devices immediately and follow recall instructions to obtain replacement or further guidance.
Quick Facts at a Glance
Recall Date
July 31, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Unknown
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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About This Product
Intracardiac echocardiography (ICE) catheters visualize cardiac structures, blood flow, and devices within the heart during electrophysiology procedures. Reprocessed versions are intended for single-use in clinical settings.
Why This Is Dangerous
The reprocessed catheters may retain particulates on surfaces that contact blood. If particulates enter the bloodstream or heart, they may trigger inflammation or infection and cause thrombus formation or embolism.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and patients may face procedure delays, additional costs, and safety concerns from switching to replacement devices.
Practical Guidance
How to identify if yours is affected
1) Locate the device label and confirm Item Number/UDI-DI D087031RH.
2) Verify the lot numbers against EP240731 EP240814 EP240826 EP240903 EP240916 EP241003 EP241014 EP241028 EP241104 EP241112 EP241202 EP241209A EP241219 EP241224 EP250114 EP250116 EP250204 EP250219.
3) Review recall notices from Medline and FDA.
Where to find product info
Recall notices and model identifiers available via FDA enforcement page and Medline recall communications.
What timeline to expect
Remedies typically issued within weeks to months; replacement or guidance will be provided by Medline.
If the manufacturer is unresponsive
Document all contact attempts with the manufacturer.
File a complaint with the FDA if the manufacturer is unresponsive.
Consult your hospital's risk management department for steps to safeguard patients.
How to prevent similar issues
Do not reprocess single-use catheters unless explicitly approved.
Verify supplier recalls before instrumenting patients.
Keep a log of device recalls and replacements.
Follow all FDA and manufacturer safety communications.
Documentation advice
Maintain the recall letter, device labels, lot numbers, and correspondence with the manufacturer. Record any adverse events and seek medical advice as needed.
Product Details
Item Number/UDI-DI: D087031RH; 10197344019557
Lots: EP240731 EP240814 EP240826 EP240903 EP240916 EP241003 EP241014 EP241028 EP241104 EP241112 EP241202 EP241209A EP241219 EP241224 EP250114 EP250116 EP250204 EP250219
Distribution: United States nationwide. International distribution pending; no international distribution.
Quantity: 7,913 units
Sold at: Unknown
Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
7,913 units recalled
Domestic US nationwide distribution; international distribution pending
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