Codman EDS 3 Drainage System with Ventricular Catheter — Class II medical device recall Z-0089-2015
Terminated recall by Codman & Shurtleff, Inc., reported 2014-10-29, distributed nationwide. tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or und
| Recall number | Z-0089-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Codman & Shurtleff, Inc., Raynham, MA, United States |
| Recall initiated | 2014-09-15 |
| Classified | 2014-10-20 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2017-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, AW, BE, BH, BO, BR, BS, CA, CH, CL, CN, CR, CY, CZ, DE, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, IE, IL, IN, IR, IT, JO, KE, KW, LB, LT, LU, LV, MX, MY, NG, NL, NO, NZ, OM, PA, PE, PL, PT, RO, RS, SA, SE, SG, SI, SK, TN, TR, TW, UA, UY, VE, ZA |
| Quantity | 66,120 units |
| Reason classes | packaging |
| Model numbers | 82-1730 |
Product
Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
Reason for recall
tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
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-0089-2015. 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.