Z-0477-2015Class II

7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near...

Name: Z-0477-2015 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near...
Creator: ZOLL Circulation, Inc.
Published: 2014-04-01
License: https://open.fda.gov/license/

ZOLL Circulation, Inc. / initiated 2014-04-01 / Terminated / root cause: manufacturing process

FDA source

ZOLL Circulation, Inc. began a recall of 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... on 2014-04-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0477-2015
Classification: Class II
Status: Terminated
Initiated: 2014-04-01
Posted: 2014-12-03
Terminated: 2014-11-26
Recalling firm: 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.
Product code: PAV Catheter, Neuro-Vasculature, Occluding Balloon
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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Hospital was notified in April 2014 of the recall by UPS.
Quantity in commerce: 1 device
Distribution: One location in NC
Product codes and lots: Model 1027, Catalog number 8700-000775-01, lot 0021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0477-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0477-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26

Product code PAV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)