Food, drugs, devices › Aesculap, Inc.
Device recall: Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended
FDA enforcement event 68091 is a device recall by Aesculap, Inc. of Center Valley, PA, initiated 21 Apr 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 20 Oct 2014. Initiation: voluntary: firm initiated. Aesculap, Inc. has 25 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aesculap, Inc., Center Valley, PA.
Reason for recall
"AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter."
Distribution
"US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1676-2014 | Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. | 48 | Class II | Terminated | 11 Jun 2014 |
Context
Other enforcement events for Aesculap, Inc.
All 25 events for Aesculap, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Oct 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.