# FDA recall Z-0003-2018

> **St Jude Medical Inc.** · Class I · device recall initiated 2017-08-28.

## Product

Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q  Product Usage	 Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing

## Reason for recall

The device may exhibit premature battery depletion.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0003-2018
- **Recalling firm:** St Jude Medical Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-28
- **Report date:** 2017-10-18
- **Termination date:** 2024-01-20

- **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-0003-2018

## Citation

> AI Analytics. FDA recall Z-0003-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0003-2018. Source: US FDA. Licensed CC0.

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