# FDA recall Z-1525-2021

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class II · device recall initiated 2021-04-06.

## Product

Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure.  1. Azure family:  Azure XT DR MRI SureScan", Azure S DR MRI SureScan, Azure XT SR  MRI SureScan, Azure S SR MRI SureScan.  2. Astra family:  Astra XT DR MRI SureScan, Astra XT SR MRI SureScan.

## Reason for recall

A longevity estimation error may occur in the  early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1525-2021
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-04-06
- **Report date:** 2021-05-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1525-2021

## Citation

> AI Analytics. FDA recall Z-1525-2021. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1525-2021. Source: US FDA. Licensed CC0.

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