Recall Z-0477-2015 ยท PAV Catheter, Neuro-Vasculature, Occluding Balloon
ZOLL Circulation, Inc.
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.
| Date | Dec 3, 2014 (initiated Apr 1, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Hospital was notified in April 2014 of the recall by UPS. |
| Quantity | 1 device |
| Distribution | One location in NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.