# FDA recall Z-2405-2026

> **Abbott Medical** · Class II · device recall initiated 2026-05-12.

## Product

Merlin" Patient Care System (PCS) software  Merlin" PCS 3650 programmer Model 3330 software

## Reason for recall

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in  programmer not successfully communicating the command to terminate the test.

## Distribution

US Nationwide distribution including in the states of  AK, 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, WY. OUS: Not provided yet

## Key facts

- **Recall number:** Z-2405-2026
- **Recalling firm:** Abbott Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-12
- **Report date:** 2026-06-17

- **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-2405-2026

## Citation

> MORVS. FDA recall Z-2405-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-2405-2026. Source: US FDA. Licensed CC0.

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