7F NeuroFlo Catheter…

Date

Dec. 3, 2014

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

ZOLL Circulation, Inc.

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

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.

Distribution pattern

One location in NC

Quantity

1 device

Codes and lots

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

Recall started

April 1, 2014

Device type

Catheter, Neuro-Vasculature, Occluding Balloon

Root cause (FDA)

Other

What the company told customers

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

Recall number

Z-0477-2015

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0477-2015. The agency record governs; check it and the company before acting.