# FDA recall Z-1564-2021

> **Medtronic Inc.** · Class III · device recall initiated 2021-03-23.

## Product

VenaSeal Closure System

## Reason for recall

Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

## Distribution

Distributed nationwide to MA, NY, VT, NH, ME

## Key facts

- **Recall number:** Z-1564-2021
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-23
- **Report date:** 2021-05-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1564-2021

## Citation

> AI Analytics. FDA recall Z-1564-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1564-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*