FDA Device recall Z-0805-2013
Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide…
- FDA Device
- Class II
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class II recall of Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide… by Aesculap, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0805-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-04 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Aesculap |
| Distribution | US |
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
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
Identifiers
| code_info | Lots 4503489878, 4503792749, 4503682927, 4503508385, 4503789879, 4503800248 and 4503682935. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Aesculap
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FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description:…
FDA Device · Class II · 2025-11-05 · Aesculap - Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description…
FDA Device · Class II · 2025-11-05 · Aesculap
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0805-2013%22
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