SHUNTASSISTANT 2.0 FX101TRecalls & reported problems
Aesculap AG · SHUNTASSISTANT 2.0 15 · Class 2 · Implant
All models of SHUNTASSISTANT 2.0 (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04041906501570), received between Aug 23, 2024 and Apr 21, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem1
- Obstruction of Flow1
Patient problems
- Hydrocephalus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2025Obstruction of Flow; Obstruction of Flow
THE RELEASE FOR EXAMINATION HAS NOW BEEN SUBMITTED AND THE INVESTIGATION COULD BE CARRIED OUT. SAME INCIDENT AS MEDWATCH# 3004721439-2025-00106 AND #3004721439-2025-00107.
Patient problems: Hydrocephalus
MAUDE report 21873231 ↗InjuryAug 23, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT A SHUNTASSISTANT (#FX101T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN OVERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 59 YEARS. HEIGHT: 175 CM. WEIGHT: 92 KG. GENDER: MALE. SAME PATIENT/ EVENT AS MED-WATCH NO.
Patient problems: Hydrocephalus
MAUDE report 20048812 ↗
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- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- proGAV 2.0® FX410TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components119 reports
- Becker® 46128Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 recall50 reports
- PROGAV 2.0 FX643TAesculap AG · Shunt, central nervous system and components100 reports
- M.BLUE PLUS FX804TAesculap AG · Shunt, central nervous system and components82 reports
- proSA® FV701TChristoph Miethke GmbH & Co. KG · Shunt, central nervous system and components82 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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