# FDA recall Z-2002-2021

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

## Product

VALITUDE CRT-P pacemaker, Models:  a) U125  b) U128

## Reason for recall

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2002-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-03
- **Report date:** 2021-07-14

- **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-2002-2021

## Citation

> AI Analytics. FDA recall Z-2002-2021. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2002-2021. Source: US FDA. Licensed CC0.

---

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