CLASS III Device recall · Reported 24 Dec 2014 · FDA Enforcement Report
Miethke Shunt System, miniNAV Valve recalled by Aesculap
Aesculap is recalling Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt, distributed in Oklahoma, Wisconsin. The recall was initiated on 11 Nov 2014 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0814-2015
- FDA event ID
- 69741
- Recalling firm
- Aesculap, Center Valley, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Nov 2014
- FDA classified
- 16 Dec 2014
- Reported
- 24 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 11 Nov 2014 | Recall initiated by company | |
| 16 Dec 2014 | Classified by FDA | +35 days |
| 24 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Distributed in OK, and WI.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Catalog No: FV660T Lot No: 4506022655
Where was it sold?
Distributed in OK, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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