Aesculap — Class II medical device recall Z-0805-2013
Terminated recall by Aesculap, Inc., reported 2013-02-20, distributed nationwide. The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm
| Recall number | Z-0805-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2012-06-04 |
| Classified | 2013-02-12 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2014-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 11 |
| Lot numbers | 4503489878, 4503508385, 4503682927, 4503682935, 4503789879, 4503792749, 4503800248 |
Product
Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Reason for recall
The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0805-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.