# FDA recall Z-2070-2019

> **St Jude Medical Inc.** · Class I · device recall initiated 2019-06-20.

## Product

ELLIPSE VR, REF: CD1377-36C    Implantable cardioverter defibrillators (ICDs)

## Reason for recall

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

## Distribution

Worldwide distribution.  US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO

## Key facts

- **Recall number:** Z-2070-2019
- **Recalling firm:** St Jude Medical Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-20
- **Report date:** 2019-08-14
- **Termination date:** 2024-04-03

- **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-2070-2019

## Citation

> AI Analytics. FDA recall Z-2070-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2070-2019. Source: US FDA. Licensed CC0.

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