CLASS II Device recall · Reported 4 Feb 2015 · FDA Enforcement Report
Miethke Shunt System accessories recalled by Aesculap
Aesculap is recalling Miethke Shunt System accessories, distributed nationwide in the US. The recall was initiated on 17 Dec 2014 and the FDA has classified it as Class II.
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-1012-2015
- FDA event ID
- 70086
- Recalling firm
- Aesculap, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2014
- FDA classified
- 26 Jan 2015
- Reported
- 4 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 17 Dec 2014 | Recall initiated by company | |
| 26 Jan 2015 | Classified by FDA | +40 days |
| 4 Feb 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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).
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US Nationwide
Questions about this recall
Is Miethke Shunt System accessories recalled?
Yes. Aesculap recalled Miethke Shunt System accessories on 17 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-1012-2015.
Why was it recalled?
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).
Which lots are affected?
material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T
Where was it sold?
Worldwide Distribution - US Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 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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