Reprocessed ViewFlex Xtra ICE Catheter to visualize recall: Particulate Matter
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Why was Reprocessed ViewFlex Xtra ICE Catheter to visualize recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
- Recalling firm
- Medline Industries, LP
- Quantity
- 7913 eaches
- Distribution
- Domestic US distribution nationwide. International distribution pending. No international distribution.
- Recall date
- October 8, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)