Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures — Class I medical device recall Z-2613-2025
Ongoing recall by Medline Industries, LP, reported 2025-10-08, distributed nationwide. Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulate
| Recall number | Z-2613-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-07-31 |
| Classified | 2025-09-26 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 7,913 eaches |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10197344019557 |
| Lot numbers | EP240731, EP240814, EP240826, EP240903, EP240916, EP241003, EP241014, EP241028, EP241104, EP241112, EP241202, EP241209A, EP241219, EP241224, EP250114, EP250116, EP250204, EP250219 |
| Model numbers | D087031RH |
Product
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2613-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.