Reprocessed Electrophysiology Catheters Recalled for Residual Particulate Contamination
Medline is recalling 7,913 reprocessed ICE catheters due to residual particulates on patient-contacting surfaces. These particles may cause infection, blood clots, or potentially fatal embolism.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class I FDA recall, indicating serious hazard potential. However, the source reports no actual illnesses, injuries, or deaths—only theoretical risks from residual particulates. Per the rubric, theoretical hazards without reported incidents cap the score at High rather than Severe.
Plain-English summary
Medline Industries is recalling 7,913 units of reprocessed ViewFlex Xtra ICE Catheters (Medline Item Number D087031RH) distributed nationwide in the United States. These catheters are used to visualize cardiac structures and blood flow during electrophysiology procedures.
The recall affects specific lot numbers: EP240731, EP240814, EP240826, EP240903, EP240916, EP241003, EP241014, EP241028, EP241104, EP241112, EP241202, EP241209A, EP241219, EP241224, EP250114, EP250116, EP250204, and EP250219. These units contain small residual particulates on patient-contacting surfaces that may have remained after reprocessing of used catheters.
If a catheter with residual particulates is used in a patient procedure, the particles could trigger an inflammatory response or systemic infection. More critically, if a particle becomes dislodged during the procedure and circulates in the bloodstream or contacts the heart, it may cause a granulomatous reaction, thrombus formation, or embolism that could result in cerebral embolism, pulmonary embolism, or deep vein thrombosis.
Healthcare facilities should immediately discontinue use of affected lot numbers and contact Medline Industries for instructions on device returns or safe disposal.
The recalled product
- Product
- Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
- Manufacturer
- Medline Industries, LP
- Hazard
- residual-particles
- systemic-infection
- thrombosis
- embolism
Distribution
Distributed nationwide across the United States.
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