# FDA recall Z-0725-2021

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2020-12-14.

## 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

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0725-2021
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-14
- **Report date:** 2020-12-30
- **Termination date:** 2021-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0725-2021

## Citation

> AI Analytics. FDA recall Z-0725-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0725-2021. Source: US FDA. Licensed CC0.

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