# FDA recall Z-2587-2025

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2025-08-15.

## Product

Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.

## Reason for recall

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2587-2025
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-15
- **Report date:** 2025-09-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2587-2025

## Citation

> AI Analytics. FDA recall Z-2587-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2587-2025. Source: US FDA. Licensed CC0.

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