Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 3, 2014
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.
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 produc…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zoll Circulation, Inc. recalled 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with tw… - a moderate-severity action.
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with tw… was recalled by Zoll Circulation, Inc. in December 3, 2014. Reason: After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by …. Check the official notice for the remedy. Verify recall #Z-0477-2015 with the FDA Devices before acting.
The recall
Zoll Circulation, Inc. issued this moderate-severity FDA Devices recall-After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by ….
- Moderate
- severity level
- 1 units
- affected scope
- Class II
- classification
- December 3, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0477-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0477-2015) was formally reported on December 3, 2014, with the manufacturer initiating the action on April 1, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Zoll Circulation, Inc. is listed as the recalling firm, operating out of San Jose, CA. Federal records list the affected scope as 1 device.
The documented reason for this recall is: 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 data in the federal record shows the product reached: One location in NC. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1 device
Related Recalls
6
3 from same agency
Product description
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 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0477-2015 |
| Date reported | December 3, 2014 |
| Date initiated | April 1, 2014 |
| Recalling firm | Zoll Circulation, Inc. |
| Firm location | San Jose, CA |
| Affected scope | 1 device |
| Distribution | One location in NC |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0477-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zoll Circulation, Inc.. Units affected: 1 device.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2014. Severity: Moderate. Recall number: Z-0477-2015.
Where was the recalled product distributed? ▼
Distribution: One location in NC.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0477-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 3, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.