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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69735

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 01, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ZOLL Circulation, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-0477-2015
Initiated
April 01, 2014
Classification
Class II
Status
Terminated
Recalling firm
ZOLL Circulation, Inc.
Quantity
1 device

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

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.

Code information

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

Distribution pattern

One location in NC