FDA Medical Device Recalls (openFDA)
ZOLL Circulation, Inc.: 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.
- Recall number
- Z-0477-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-04-01
- Posted
- 2014-12-03
- Terminated
- 2014-11-26
- 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.
- Root cause
- Other
- Action
- Hospital was notified in April 2014 of the recall by UPS.
- Quantity
- 1 device
- Distribution
- One location in NC
- Lot, serial or model codes
- Model 1027, Catalog number 8700-000775-01, lot 0021.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PAV
- Firm FEI
- 3003793491
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28