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Recall Observatory FDA recall evidence

Device 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.

Z-0477-2015

April 01, 2014

Class II

Product summary

Firm
ZOLL Circulation, Inc.
Event
Event 69735
Status
Terminated
Classification
Class II
Quantity
1 device
Official record key
device-enforcement:Z-0477-2015

Official wording

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.

Code information: Model 1027, Catalog number 8700-000775-01, lot 0021.

Distribution pattern: One location in NC

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.