FDA Medical Device Recalls (openFDA)
Aesculap, Inc.: Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
- Recall number
- Z-1012-2015
- Recalling firm
- Aesculap, Inc.
- Product
- Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
- Status
- Terminated
- Initiated
- 2014-12-17
- Posted
- 2015-01-26
- Terminated
- 2016-12-13
- Reason
- Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).
- Root cause
- Labeling False and Misleading
- Action
- Aesculap sent an Important Correction and Removal and Field Safety Notification letter, dated December 17, 2014, to all affected customers. The letter identiifed the affected product, problem, and actions to be taken. Customers were requested to remove from inventory and contact Aesculap regarding return of the affected devices and acknowledgement form.
- Quantity
- 772
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T
- 510(k) numbers
- ["K120559"]
- 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