# FDA recall Z-2322-2018

> **St Jude Medical Inc.** · Class II · device recall initiated 2018-04-16.

## Product

Promote, Sterile EO, Model #/ Part #:   3207-30/60010740-207, 60010740-407;   3207-36/60010743-207, 60010743-407;   3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707;   CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194;   CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054;   CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065;   CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906

## Reason for recall

The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.

## Distribution

U.S. Nationwide distribution

## Key facts

- **Recall number:** Z-2322-2018
- **Recalling firm:** St Jude Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-16
- **Report date:** 2018-07-04
- **Termination date:** 2024-03-08

- **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-2322-2018

## Citation

> AI Analytics. FDA recall Z-2322-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2322-2018. Source: US FDA. Licensed CC0.

---

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