# FDA recall Z-0822-2025

> **Boston Scientific Corporation** · Class I · device recall initiated 2024-12-12.

## Product

ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)

## Reason for recall

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

## Distribution

US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.

## Key facts

- **Recall number:** Z-0822-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-12
- **Report date:** 2025-01-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0822-2025

## Citation

> AI Analytics. FDA recall Z-0822-2025. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0822-2025. Source: US FDA. Licensed CC0.

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