# FDA recall Z-0753-2025

> **Abbott Medical** · Class II · device recall initiated 2024-11-21.

## Product

The Merlin PCS 3650 programmer Model 3330    The Merlin PCS programmer model 3650 is a portable, dedicated  programming system which operates using the Merlin PCS Model 3330  software and is designed to interrogate, program, display data from, and test  Abbott Medical implantable devices and leads.

## Reason for recall

Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the  Programmer displays a loss of telemetry detected window, and there is no pacing.

## Distribution

Worldwide - U.S. 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, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN TX, UT, VA, WA, WI, and WV. The countries of Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-0753-2025
- **Recalling firm:** Abbott Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-21
- **Report date:** 2025-01-01

- **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-0753-2025

## Citation

> AI Analytics. FDA recall Z-0753-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0753-2025. Source: US FDA. Licensed CC0.

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