# FDA recall Z-2271-2023

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2023-06-28.

## Product

ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000.  Component of a chest stabilization system for cardiac and chest surgery.

## Reason for recall

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

## Distribution

Worldwide distribution - US Nationwide and the countries of Bangladesh, Brazil, Chile, Colombia, Iran, Jordan, Malaysia, Mexico, Netherlands, Singapore, Sudan, Taiwan, Thailand, and United Arab Emirates.

## Key facts

- **Recall number:** Z-2271-2023
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-28
- **Report date:** 2023-08-09

- **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-2271-2023

## Citation

> AI Analytics. FDA recall Z-2271-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2271-2023. Source: US FDA. Licensed CC0.

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