# FDA recall Z-1351-2020

> **St Jude Medical, Cardiac Rhythm Management Division** · Class II · device recall initiated 2020-01-22.

## Product

Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330

## Reason for recall

Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.

## Distribution

U.S.: WV, MS, TX, DE, OH, AZ, MI, NC, KY, WA, NY, CA, IN, MO, MD, NJ, FL, PA, OK.    O.U.S.: United Kingdom, Turkey, Sweden, Spain, Portugal, Poland, Philippines, Pakistan, Norway, New Zealand, Netherlands, Japan, Italy, Hong Kong, Greece, Germany, France, Finland, Denmark, Canada, Belgium, Austria, Australia

## Key facts

- **Recall number:** Z-1351-2020
- **Recalling firm:** St Jude Medical, Cardiac Rhythm Management Division
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-22
- **Report date:** 2020-03-04
- **Termination date:** 2020-12-17

- **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-1351-2020

## Citation

> AI Analytics. FDA recall Z-1351-2020. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1351-2020. Source: US FDA. Licensed CC0.

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