Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed… — Class II medical device recall Z-0725-2021
Terminated recall by Integra LifeSciences Corp., reported 2020-12-30, distributed nationwide. Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal
| Recall number | Z-0725-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2020-12-14 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2021-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 17 units |
| Reason classes | labeling |
| Lot numbers | 4178257 |
| Model numbers | 823087 |
| Expiration dates | 2019-11-20 |
Product
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087
Reason for recall
Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa
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-0725-2021. 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.