FDA Medical devices recall ·
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2613-2025
- Date
- (initiated July 31, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 7913 eaches
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Domestic US distribution nationwide. International distribution pending. No international distribution.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2613-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.