# FDA recall Z-1695-2024

> **Abbott Medical** · Class II · device recall initiated 2024-02-05.

## Product

Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

## Reason for recall

Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

## Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. OUS: Pending

## Key facts

- **Recall number:** Z-1695-2024
- **Recalling firm:** Abbott Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-05
- **Report date:** 2024-05-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sylmar, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1695-2024

## Citation

> AI Analytics. FDA recall Z-1695-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1695-2024. Source: US FDA. Licensed CC0.

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