# FDA recall Z-0022-2018

> **St. Jude Medical, Inc.** · Class II · device recall initiated 2017-09-12.

## Product

Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667

## Reason for recall

Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.

## Distribution

Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)

## Key facts

- **Recall number:** Z-0022-2018
- **Recalling firm:** St. Jude Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-12
- **Report date:** 2017-10-25
- **Termination date:** 2020-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plano, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0022-2018

## Citation

> AI Analytics. FDA recall Z-0022-2018. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0022-2018. Source: US FDA. Licensed CC0.

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