UltraFlow HPC Flow Directed Micro Catheter — Class II medical device recall Z-2471-2012
Terminated recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, reported 2012-10-03, distributed nationwide. The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Cat
| Recall number | Z-2471-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular, Irvine, CA, United States |
| Recall initiated | 2011-09-23 |
| Classified | 2012-09-27 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2012-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BR, CZ, DE, FR, GB, NL, PL |
| Quantity | 36 units |
| Reason classes | labeling |
| Lot numbers | 9374298 |
| Model numbers | 105-5065 |
Product
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Reason for recall
The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
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-2471-2012. 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.