FDA Medical Device Recalls (openFDA)
Aesculap, Inc.: Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
- Recall number
- Z-0814-2015
- Recalling firm
- Aesculap, Inc.
- Product
- Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
- Status
- Terminated
- Initiated
- 2014-11-11
- Posted
- 2014-12-16
- Terminated
- 2015-06-09
- Reason
- Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.
- Root cause
- Labeling Change Control
- Action
- An important correction & removal notification, dated November 11, 2014, was sent to consignees that identified the product, problem, and action to be taken. Consignees were asked to complete the distribution inventory sheet and return it. Aesculap sales representatives would be coordinating pick up of affected devices.
- Quantity
- 4
- Distribution
- Distributed in OK, and WI.
- Lot, serial or model codes
- Catalog No: FV660T Lot No: 4506022655
- 510(k) numbers
- ["K110206"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- 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