7F NeuroFlo Catheter — Class II medical device recall Z-0477-2015
Terminated recall by ZOLL Circulation, Inc., reported 2014-12-03, distributed in NC. After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by a
| Recall number | Z-0477-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ZOLL Circulation, Inc., San Jose, CA, United States |
| Recall initiated | 2014-04-01 |
| Classified | 2014-11-26 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2014-11-26 |
| Distributed | NC |
| Quantity | 1 devices |
| Lot numbers | 0021 |
| Model numbers | 1027, 8700-000775-01 |
Product
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is under Humanitarian Device Exemption and not commercially released under a premarket notification or premarket approval.
Reason for recall
After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed.
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-0477-2015. 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.