Medline Industries, LP — Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 31, 2025
Domestic US distribution nationwide. International distribution pending. No international distribution.
What's affected?
- Product
- Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
- Lot code
- EP240731
Additional 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
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 7913 eaches.
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