Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0477-2015·Announced 2014-12-03

ZOLL Recalls NeuroFlo Catheter Due to Missing Regulatory Filing

ZOLL Circulation is recalling one lot of NeuroFlo Catheters because a required regulatory supplement was not filed after the company acquired the product's assets.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that no illnesses or injuries were reported and the hazard is a regulatory documentation issue (missing HDE supplement) rather than a direct physical defect or contamination.

Plain-English summary

ZOLL Circulation, Inc. is recalling one lot of 7F NeuroFlo Catheters, Model 1027. The NeuroFlo Catheter is a multi-lumen medical device with two balloons mounted near the distal tip, used for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The device is under a Humanitarian Device Exemption (HDE) and is not commercially released under a premarket notification or premarket approval.

The recall was initiated after ZOLL acquired the assets of CoAxia and discovered that one lot of NeuroFlo Catheters was manufactured by another firm. During this review, it was determined that a Humanitarian Device Exemption (HDE) supplement listing ZOLL as the owner of the product had not been filed. The affected product is identified by Model 1027, Catalog number 8700-000775-01, and lot 0021.

The recall involves one device distributed to one location in North Carolina. The source text does not report any illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers who have this specific lot of the device should contact ZOLL Circulation, Inc. for further instructions.

The recalled product

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…
Manufacturer: ZOLL Circulation, Inc.
Category: Medical Device — Neurological Catheter
Hazard: regulatory-non-compliance
documentation-error
Affected units: 1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed in 1 state:

Same manufacturer · ZOLL Circulation, Inc.

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