# FDA recall Z-0421-2024

> **Medtronic Inc.** · Class II · device recall initiated 2023-11-03.

## Product

ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor

## Reason for recall

It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.

## Distribution

US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, Macao, Malaysia, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom

## Key facts

- **Recall number:** Z-0421-2024
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-03
- **Report date:** 2023-12-06

- **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-0421-2024

## Citation

> AI Analytics. FDA recall Z-0421-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0421-2024. Source: US FDA. Licensed CC0.

---

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