# FDA recall Z-0357-2018

> **Boston Scientific Corporation** · Class II · device recall initiated 2017-12-07.

## Product

ACCOLADE MRI SR Pacemaker

## Reason for recall

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

## Distribution

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

## Key facts

- **Recall number:** Z-0357-2018
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-12-07
- **Report date:** 2018-01-24

- **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-0357-2018

## Citation

> AI Analytics. FDA recall Z-0357-2018. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/Z-0357-2018. Source: US FDA. Licensed CC0.

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