# FDA recall Z-1497-2022

> **St. Jude Medical, Cardiac Rhythm Management Division** · Class II · device recall initiated 2022-06-17.

## Product

Merlin.net model MN5000 Software

## Reason for recall

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming  system designed to interrogate, program, display data from, and test Abbott  Medical implantable medical devices during implant and follow-up.

## Distribution

US: 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	VI	VT	WA	WI	WV	WY	, Guam  OUS: ALBANIA	ALGERIA	ANGOLA	Argentina	ARMENIA	Australia	AUSTRIA	AZERBAIJAN	BAHRAIN	Bangladesh	BELGIUM	BENIN	BOLIVIA	BOSNIA-HERZ.	BRAZIL	BULGARIA	Burnei	Cambodia	CAMEROON	Canada	Chile	China 	Colombia	COTE D'IVOIRE	CUBA	CYPRUS	CZECH REPUBLIC	DENMARK	DOMINICAN REP.	ECUADOR	EGYPT	EL SALVADOR	ESTONIA	ETHIOPIA	FAROE ISLANDS	FINLAND	FRANCE	GEORGIA	GERMANY	GREECE	GREENLAND	GUATEMALA	Hong Kong	HUNGARY	ICELAND	India	Indonesia	IRELAND	ISRAEL	ITALY	JORDAN	KAZAKHSTAN	KOSOVO	KUWAIT	KYRGYZSTAN	LATVIA	LEBANON	LIBYA	LIECHTENSTEIN	LITHUANIA	LUXEMBOURG	MACEDONIA	Malaysia	MALTA	MAURITIUS	Mexico	MONGOLIA	MONTENEGRO	MOROCCO	Myanmar	Nepal	NETHERLANDS	New Zealand	NORWAY	OMAN	Pakistan	PALESTINE	PANAMA	PARAGUAY	PERU	Philippines	POLAND	PORTUGAL	QATAR	ROMANIA	RUSSIAN FED.	SAUDI ARABIA	SENEGAL	Singapore	SLOVAKIA	SLOVENIA	SOUTH AFRICA	South Korea	

## Key facts

- **Recall number:** Z-1497-2022
- **Recalling firm:** St. Jude Medical, Cardiac Rhythm Management Division
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-17
- **Report date:** 2022-08-10

- **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-1497-2022

## Citation

> AI Analytics. FDA recall Z-1497-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1497-2022. Source: US FDA. Licensed CC0.

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