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Terminated

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.

FDA Recall Z-0477-2015 · Posted 2014-12-03

Recalling FirmZOLL Circulation, Inc.
Recall StatusTerminated
Product CodePAV
Date Initiated2014-04-01
Date Terminated2014-11-26
Product Quantity1 device

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.

Firm Action

Hospital was notified in April 2014 of the recall by UPS.

Root Cause

Other

Distribution Pattern

One location in NC

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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