# FDA recall Z-2019-2021

> **Boston Scientific Corporation** · Class I · device recall initiated 2021-06-03.

## Product

INTUA CRT-P, Model Numbers:   a) V272  b) V273  c) W273

## Reason for recall

The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2019-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-03
- **Report date:** 2021-07-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2019-2021

## Citation

> AI Analytics. FDA recall Z-2019-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2019-2021. Source: US FDA. Licensed CC0.

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