Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and… — Class I medical device recall Z-2614-2025
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-2614-2025 |
|---|---|
| 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 | 10197344026500, 10197344026517 |
| Lot numbers | EP240731, EP240814, EP240826, EP240903, EP240916, EP241003, EP241014, EP241021, EP241028, EP241104, EP241112, EP241114, EP241202, EP241209A, EP241219, EP241224, EP241226, EP250114, EP250116, EP250204, EP250213, EP250219 |
| Model numbers | 10135910RH, 10135936RH |
Product
Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. Medline Item Numbers 10135910RH 10135936RH
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-2614-2025. 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.