# FDA recall Z-0740-2021

> **Medtronic Neurosurgery** · Class II · device recall initiated 2020-12-08.

## Product

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only.  Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

## Reason for recall

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

## Distribution

Worldwide Distribution.  US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam

## Key facts

- **Recall number:** Z-0740-2021
- **Recalling firm:** Medtronic Neurosurgery
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-08
- **Report date:** 2021-01-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0740-2021

## Citation

> AI Analytics. FDA recall Z-0740-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0740-2021. Source: US FDA. Licensed CC0.

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