# FDA recall Z-3258-2018

> **Boston Scientific Corporation** · Class II · device recall initiated 2018-09-10.

## Product

VALITUDE  X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

## Reason for recall

Boston Scientific has identified a subset of   active pacemaker and CRT-Ps systems with an  elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.

## Distribution

AK, AL, AR, AZ, CA, CO,  CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,  LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY,  OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY

## Key facts

- **Recall number:** Z-3258-2018
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-10
- **Report date:** 2018-10-03
- **Termination date:** 2019-11-04

- **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-3258-2018

## Citation

> AI Analytics. FDA recall Z-3258-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-3258-2018. Source: US FDA. Licensed CC0.

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