# FDA recall Z-1523-2021

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

## Product

CRT-P Quad Models (CRT-Ps):  a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04   b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05  c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06.    implantable medical devices used to treat arrhythmias related to bradycardia, and cardiac resynchronization therapy (CRT)

## Reason for recall

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-1523-2021
- **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-1523-2021

## Citation

> AI Analytics. FDA recall Z-1523-2021. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-1523-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*