# FDA recall Z-2507-2020

> **Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)** · Class II · device recall initiated 2020-06-04.

## Product

Azure XT DR MRI, Model Numbers:  a) W1DR01 and b) W2DR01

## Reason for recall

There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT").  This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-2507-2020
- **Recalling firm:** Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-06-04
- **Report date:** 2020-07-15

- **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-2507-2020

## Citation

> AI Analytics. FDA recall Z-2507-2020. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-2507-2020. Source: US FDA. Licensed CC0.

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